DOCSLIB.ORG

Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 24487 that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit. telephone (202) 267–9167; email hal.jensen@ levels of government. faa.gov. For the reasons discussed above, I (d) Subject (2) Bell Helicopter Textron Alert Service certify that this AD: Joint Aircraft Service Component (JASC) Bulletin No. 206L–04–132, Revision A, dated (1) Is not a ‘‘significant regulatory Code: 2842, Fuel Quantity Sensor. October 4, 2004, which is not incorporated action’’ under Executive Order 12866, by reference, contains additional information (e) Unsafe Condition (2) Will not affect intrastate aviation about the subject of this AD. For service in Alaska, and This AD was prompted by a manufacturing information identified in this AD, contact (3) Will not have a significant flaw that could cause a switch unit to hang Bell Textron Canada Limited, 12,800 Rue de in the high position and fail to indicate a low l’Avenir, Mirabel, Quebec J7J1R4; telephone economic impact, positive or negative, fuel condition. The FAA is issuing this AD (450) 437–2862 or (800) 363–8023; fax (450) on a substantial number of small entities to prevent failure of the switch unit to 433–0272; or at https:// under the criteria of the Regulatory indicate a low fuel condition that could lead www.bellcustomer.com. You may view this Flexibility Act. to fuel exhaustion and which if not referenced service information at the FAA, addressed, could result in a subsequent Office of the Regional Counsel, Southwest List of Subjects in 14 CFR Part 39 forced landing. Region, 10101 Hillwood Pkwy., Room 6N– 321, Fort Worth, TX 76177. For information Air transportation, Aircraft, Aviation (f) Compliance safety, Incorporation by reference, on the availability of this material at the Comply with this AD within the Safety. FAA, call (817) 222–5110. compliance times specified, unless already (3) The subject of this AD is addressed in The Amendment done. Transport Canada AD CF–2004–24, dated November 24, 2004. You may view the (g) Required Actions Accordingly, under the authority Transport Canada AD on the internet at delegated to me by the Administrator, (1) For a switch unit identified in https://www.regulations.gov in Docket No. the FAA amends 14 CFR part 39 as paragraph (c)(1) of this AD, on or before the FAA–2006–25084. follows: next 100-hour time-in-service inspection after the effective date of this AD, remove the (j) Material Incorporated by Reference PART 39—AIRWORTHINESS switch unit from service. None. DIRECTIVES (2) For a switch unit identified in paragraph (c)(2) of this AD, on or before the Issued on April 28, 2021. Lance T. Gant, ■ 1. The authority citation for part 39 next 100-hour time-in-service inspection continues to read as follows: after the effective date of this AD: Director, Compliance & Airworthiness (i) Determine the color of the switch unit Division, Aircraft Certification Service. Authority: 49 U.S.C. 106(g), 40113, 44701. mounting flange. If the mounting flange color [FR Doc. 2021–09278 Filed 5–6–21; 8:45 am] is any color other than red, determine the § 39.13 [Amended] purchase date. If the purchase date of the BILLING CODE 4910–13–P ■ 2. The FAA amends § 39.13 by adding switch unit is between April 19 and July 26, the following new airworthiness 2004, or cannot be determined, do an operational test. DEPARTMENT OF JUSTICE directive: (ii) If the switch unit fails the operational 2021–10–08 Bell Textron Canada Limited test, before further flight, remove the switch Drug Enforcement Administration (Type Certificate Previously Held by Bell unit from service. Helicopter Textron Canada Limited): (3) As of the effective date of this AD, do 21 CFR Part 1308 Amendment 39–21541 Docket No. FAA– not install a switch unit identified in 2006–25084; Project Identifier 2005– paragraph (c)(1) of this AD on any helicopter. [Docket No. DEA–808] SW–38–AD. (4) As of the effective date of this AD, do not install a switch unit identified in Schedules of Controlled Substances: (a) Effective Date paragraph (c)(2) of this AD on any helicopter Placement of Serdexmethylphenidate This airworthiness directive (AD) is unless the actions in paragraphs (g)(2)(i) and in Schedule IV effective June 11, 2021. (ii) of this AD have been accomplished. AGENCY: Drug Enforcement (b) Affected ADs (h) Alternative Methods of Compliance Administration, Department of Justice. (AMOCs) None. ACTION: Interim final rule with request (1) The Manager, International Validation (c) Applicability Branch, FAA, has the authority to approve for comments. This AD applies to Bell Textron Canada AMOCs for this AD, if requested using the SUMMARY: On March 2, 2021, the United Limited (type certificate previously held by procedures found in 14 CFR 39.19. In Bell Helicopter Textron Canada Limited) accordance with 14 CFR 39.19, send your States Food and Drug Administration Model 206L, 206L–1, 206L–3, and 206L–4 request to your principal inspector or local approved a new drug application for helicopters, certificated in any category, with Flight Standards District Office, as AZSTARYS capsules for oral use, a a low fuel level detector switch unit (switch appropriate. If sending information directly combination drug product containing unit) part number (P/N) 206–063–613–003: to the manager of the International Validation serdexmethylphenidate chloride and VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\07MYR1.SGM 07MYR1 24488 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations dexmethylphenidate hydrochloride, for your comment has been successfully received. If you want to submit personal the treatment of Attention Deficit submitted and there is no need to identifying information (such as your Hyperactivity Disorder in patients six resubmit the same comment. name, address, etc.) as part of your years of age or older. The Department of • Paper comments: Paper comments comment, but do not want it to be made Health and Human Services provided that duplicate the electronic submission publicly available, you must include the the Drug Enforcement Administration are not necessary and are discouraged. phrase ‘‘PERSONAL IDENTIFYING with a scheduling recommendation to Should you wish to mail a paper INFORMATION’’ in the first paragraph place serdexmethylphenidate and its comment in lieu of an electronic of your comment. You must also place salts in schedule IV of the Controlled comment, it should be sent via regular all of the personal identifying Substances Act. In accordance with the or express mail to: Drug Enforcement information you do not want made Controlled Substances Act, as amended Administration, Attn: DEA Federal publicly available in the first paragraph by the Improving Regulatory Register Representative/DPW, 8701 of your comment and identify what Transparency for New Medical Morrissette Drive, Springfield, VA information you want redacted. If you Therapies Act, Drug Enforcement 22152. want to submit confidential business Administration is hereby issuing an • Hearing requests: All requests for information as part of your comment, interim final rule placing hearing and waivers of participation but do not want it to be made publicly serdexmethylphenidate, including its must be sent to: Drug Enforcement available, you must include the phrase salts, isomers, and salts of isomers, in Administration, Attn: Administrator, ‘‘CONFIDENTIAL BUSINESS schedule IV of the Controlled 8701 Morrissette Drive, Springfield, INFORMATION’’ in the first paragraph Substances Act, thereby facilitating the Virginia 22152. All requests for hearing of your comment. You must also commercial distribution of AZSTARYS and waivers of participation should also prominently identify the confidential as a lawful controlled substance. be sent to: (1) Drug Enforcement business information to be redacted DATES: The effective date of this Administration, Attn: Hearing Clerk/ within the comment. Comments containing personal rulemaking is May 7, 2021. Interested OALJ, 8701 Morrissette Drive, identifying information and confidential persons may file written comments on Springfield, Virginia 22152; and (2) business information identified as this rulemaking in accordance with 21 Drug Enforcement Administration, Attn: directed above will generally be made U.S.C. 811(j)(3) and 21 CFR 1308.43(g).
Load more

Recommended publications
  • Drug Information Center Highlights of FDA Activities
    Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device.
    [Show full text]
  • Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
    Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics
    [Show full text]
  • PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
    PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025.
    [Show full text]
  • Psychiatric Medication Update Objectives Abbreviations
    3/30/2021 Psychiatric Medication Update Kara Gagnon, PharmD, BCPS, BCPP Pharmacy & Behavioral Health Programs Manager Objectives Identify newly approved psychiatric medications Discuss medications currently in the pipeline Review pertinent FDA MedWatch Alerts Evaluate new treatment guidelines for schizophrenia Abbreviations ADHD: Attention Deficit Hyperactivity Disorder AP: Antipsychotic CNS: Central Nervous System FDA: Food and Drug Administration FGA: First Generation Antipsychotic SGA: Second Generation Antipsychotic VMAT2: Vesicular monoamine transporter 2 1 3/30/2021 FDA Drug Approval Process ✓ Drug developed ✓ Animals tested ✓ Investigational New Drug (IND) application ✓ Phase 1 → Phase 2 → Phase 3 trials ✓ Review meeting: FDA + drug sponsor ✓ New Drug Application ✓ FDA NDA Review ✓ Drug Labeling ✓ Manufacturer facility inspection ✓ Drug Approval ✓ Post-Marketing monitoring Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download FDA Drug Approval Process Faster Approval Options ➢ Accelerated Approval ➢ Fast Track Prescription Drug User Fee Act (1992) FDA MedWatch ➢ Voluntary system for physicians and consumers to report adverse events Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download AzstarysTM (serdexmethylphenidate/dexmethylphenidate) FDA Approval: March 2, 2021 CNS stimulant for treatment of ADHD in patients 6 years of age and older Norepinephrine dopamine reuptake inhibitor; Schedule II substance KemPharm, Inc. ➢ LAT® (Ligand Activated Therapy) technology Azstarys. Package Insert. KemPharm Inc. 2021. 2 3/30/2021 AzstarysTM (serdexmethylphenidate/dexmethylphenidate) Novel once-daily oral capsule ➢ First and only product with dexmethylphenidate prodrug Three strengths available ➢ 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg Warnings & Precautions ➢ Abuse/dependence, cardiovascular, psychiatric, growth suppression Azstarys.
    [Show full text]
  • (KPIC) PPO and Out-Of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier
    Kaiser Permanente Insurance Company (KPIC) PPO and Out-of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier This Drug Formulary was updated: September 1, 2021 NOTE: This drug formulary is updated often and is subject to change. Upon revision, all previous versions of the drug formulary are no longer in effect. This document contains information regarding the drugs that are covered when you participate in the California Nongrandfathered PPO and Out-of- Area Indemnity (OOA) Health Insurance Plans with specialty drug tier offered by Kaiser Permanente Insurance Company (KPIC) and fill your prescription at a MedImpact network pharmacy. Access to the most current version of the Formulary can be obtained by visiting kp.org/kpic-ca-rx-ppo-ngf. For help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit, please call 1-800-788-0710 or 711 (TTY) Monday through Friday, 7a.m. to 7p.m. For help with this Formulary, including the processes for submitting an exception request and requesting prior authorization and step therapy exceptions, please call MedImpact 24 hours a day, 7 days a week, at 1-800-788-2949 or 711 (TTY). For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit: kp.org/kpic-ca-rx-ppo-ngf. For help in your preferred language, please see the Kaiser Permanente Insurance Company Notice of Language Assistance in this document. KPIC PPO NGF Table of Contents Informational Section................................................................................................................................2
    [Show full text]
  • Attention Deficit Hyperactivity Disorder Stimulant Medications
    Cigna National Formulary Coverage Policy Step Therapy Attention Deficit Hyperactivity Disorder Stimulant Medications Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 14123 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 4 References .......................................................... 5 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • Psychiatric Medication Update
    Psychiatric Medication Update Jeffrey Bowers R.Ph., BCPP Clinical Psychiatric Pharmacist Cox North Hospital Pharmacy Springfield Missouri Objectives Discuss the meaning of New Medication Review new medications Learn to evaluate medications A New Medication for Weight Loss What does that mean? Obesity is now “cured”? For some patients, obesity is “cured”? https://contrave.com/about/ Usual dosage: Two tablets (naltrexone 16 mg/bupropion 180 mg) twice daily Contrave Contrave (bupropion/naltrexone) is a combination product used to promote and maintain weight loss in obese adults or overweight adults who have weight related medical problems. Contrave is the most popular opioid antagonist/atypical antidepressant combinations. There are currently no generic alternatives to Contrave. GoodRx: https://www.goodrx.com/contrave?dosage=8mg-90mg&form=tablet&label_override=Contrave&quantity=120&sort_type=popularity Pharmacology Demystified How does naltrexone work? New Drug? A New Drug Hits The Market The Drug Development Process Step 1: Discovery and Development Step 2: Preclinical Research Step 3: Clinical Research Step 4: FDA Drug Review Step 5: FDA Post-Market Drug Safety Monitoring https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring Phase 1 Trial Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Gather information about how a drug interacts with the human body Researchers adjust dosing schemes
    [Show full text]
  • Corium Launches Innovative ADHD Treatment AZSTARYSTM (Serdexmethylphenidate and Dexmethylphenidate) in the U.S
    CORIUM PRESS RELEASE AZSTARYS LAUNCH ANNOUNCEMENT Corium Launches Innovative ADHD Treatment AZSTARYSTM (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older AZSTARYS is the First and Only Product Containing Prodrug of Dexmethylphenidate Unique formulation provides rapid and extended duration symptom control Boston, MA, July 21, 2021 (PR NEWSWIRE) – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces that the innovative AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older. AZSTARYS, approved by the U.S. Food and Drug Administration (FDA) in March 2021, is the first and only product containing SDX, an extended-release oral prodrug of d-MPH. AZSTARYS is available as a once-daily oral capsule in three doses. Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS. AZSTARYS, classified by the U.S. Drug Enforcement Administration as a Schedule II therapy, includes a combination of 70 percent extended-release prodrug of d-MPH SDX (Schedule IV) and 30 percent immediate-release d-MPH (Schedule II). The Prescribing Information for AZSTARYS includes a Boxed Warning stating CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. “The launch of AZSTARYS provides patients with ADHD, their caregivers, and their clinicians with a first-of-its-kind treatment that offers both rapid and extended ADHD symptom improvement because of the dual action of its formulation using the prodrug SDX with IR MPH,” said Perry J.
    [Show full text]
  • U.S. Food and Drug Administration Approves Novel Once-Daily Capsule AZSTARYSTM (Serdexmethylphenidate and Dexmethylphenidate), F
    U.S. Food and Drug Administration Approves Novel Once-Daily Capsule AZSTARYSTM (serdexmethylphenidate and dexmethylphenidate), First and Only Product Containing Dexmethylphenidate Prodrug for ADHD in Patients Age 6 Years and Older Boston, MA, March 3, 2021 (PR NEWSWIRE) – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) approval of once-daily oral capsule AZSTARYSTM (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), the first and only product containing a d-MPH oral prodrug for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older. AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day. The result is a therapy designed to provide symptom control both rapidly with the d-MPH and for an extended duration with SDX. The dual action of AZSTARYS is designed to address the unmet needs in the market, including early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule. The Prescribing Information for AZSTARYS includes a Boxed Warning stating CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. “The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with d-methylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” said Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine and lead investigator of the pivotal AZSTARYS clinical trial.
    [Show full text]
  • ADHD Narcolepsy
    ADHD Narcolepsy Override(s) Approval Duration Prior Authorization 1 year Quantity Limit Quantity Limit All agents May be subject to quantity limit Medications Preferred Products Atomoxetine: Strattera generic Clonidine (extended release): Kapvay generic Dexmethylphenidate: Focalin generic Focalin XR generic Dextroamphetamine and Amphetamine: Adderall generic Adderall XR generic Dextroamphetamine: Dexedrine tablet generic Dexedrine capsules generic Methylphenidate: Metadate ER generic methylphenidate products, except: chewable tablets and ER 72mg tablets Non-Preferred Products Atomoxetine: Strattera Brand Amphetamine: Dyanavel XR Adzenys ER Suspension (and generic) Adzenys XR-ODT PAGE 1 of 9 07/20/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0716-21 Market Applicability Market GA MD NJ NY Applicable X NA X X Clonidine (extended release): Kapvay Brand Guanfacine (extended release): Intuniv and generic Dextroamphetamine and Amphetamine: Adderall Brand Adderall XR Brand Mydayis ER Dextroamphetamine: Dexedrine spansules Brand Dexmethylphenidate: Focalin Brand Focalin XR Brand Transdermal Methylphenidate: Daytrana Dextroamphetamine: ProCentra solution (and generic) Zenzedi Brand Methylphenidate: Adhansia XR Aptensio XR (and generic) Concerta Brand Cotempla XR - ODT Jornay PM Metadate CD Brand Methylin Brand Methylin ER Brand Methylphenidate chewable tablets Methylphenidate ER 72mg tablets Relexxii ER 72mg tablets Ritalin Brand Ritalin LA Brand Quillichew ER Brand Quillivant XR Brand Serdexmethylphenidate and Dexmethylphenidate: Azstarys PAGE 2 of 9 07/20/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare.
    [Show full text]
  • Drug Update for Apr-2021
    1 | P a g eKMCH INSTITUTE OF HEALTH SCIENCES New AND Drug RESEARCH Update (A unit of Kovai Medical Center and Hospital Limited) Coimbatore, Tamil Nadu Department of Pharmacology New Drug Update (New Drugs and Available Drugs with New Formulation) New drugs approved by FDA 1. Idecabtagene vicleucel 2. Dasiglucagon Nothing Worth Having Comes Easy 3. Ponesimod 4. Oritavancin 5. Tivozanib Series - 21 6. Dexmethylphenidate and April 2021 Serdexmethylphenidate Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore Kindly Mail Your Suggestions To: [email protected] 2 | P a g e New Drug Update 1. Idecabtagene vicleucel 2. Dasiglucagon Date of Approval: March 26, 2021 Date of Approval: March 22, 2021 Mechanism of action: B-cell Mechanism of action: Glucagon maturation antigen (BCMA)-directed analogue genetically modified autologous Indication: Severe hypoglycemia in chimeric antigen receptor (CAR) T cell diabetes patients aged 6 years and immunotherapy older Indication: Relapsed or refractory Dosage Formulation: Prefilled multiple myeloma autoinjector for subcutaneous injection Dosage Formulation: Intravenous Infusion 3. Ponesimod 4. Oritavancin Date of Approval: March 18, 2021 Date of Approval: March 12, 2021 Mechanism of action: Selective Mechanism of action: Lipoglycopeptide sphingosine-1-phosphate receptor 1 antibiotic acts by inhibiting cell wall (S1P1) modulator synthesis Indication: Relapsing Multiple Indication: Acute bacterial skin and Sclerosis skin structure Infection Dosage Formulation: Tablet Dosage Formulation:
    [Show full text]
  • D Rug U Tilization R Eview B Oard
    Wednesday, July 14, 2021 4:00pm Review Board Review Oklahoma Health Care Authority (OHCA) 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 Viewing Access Only: Please register for the webinar at: https://zoom.us/webinar/register/WN_D0er6gV1R8mZvxCQmI3BGg After registering, you will receive a confirmation email containing information about joining the webinar. Drug Utilization The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – July 14, 2021 DATE: July 7, 2021 NOTE: The DUR Board will meet at 4:00pm at the Oklahoma Health Care Authority (OHCA) at 4345 N. Lincoln Blvd. in Oklahoma City, Oklahoma. There will be Zoom access to this meeting; however, Zoom access will be set up in view-only mode with no voting, speaking, video, or chat box privileges. Zoom access will allow for viewing of the presentation slides as well as audio of the presentations and discussion during the meeting; however, the DUR Board meeting will not be delayed or rescheduled due to any technical issues that may arise. Viewing Access Only via Zoom: Please register for the meeting at: https://zoom.us/webinar/register/WN_D0er6gV1R8mZvxCQmI3BGg After registering, you will receive a confirmation email containing information about joining the webinar. Enclosed are the following items related to the July meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Update on Medication Coverage Authorization Unit/Chronic Medication Adherence (CMA) Program Update – Appendix B Action Item – Vote to Prior Authorize Lybalvi™ (Olanzapine/Samidorphan) – Appendix C ORI-4403 • P.O.
    [Show full text]