California Department of Public Health ADAP Formulary
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Crofelemer Oral Delayed Release Tablet
Contains Nonbinding Recommendations Draft – Not for Implementation Draft Guidance on Crofelemer This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Crofelemer Dosage Form; Route: Tablet, delayed release; oral Strength: 125 mg Recommendations for the Assessment of Identity and Quality of Botanical Raw Material (BRM): Crofelemer is a botanical drug derived from BRM, the crude red latex of Croton lechleri Müll. Arg. [Fam. Euphorbiacae], which is also called dragon’s blood (sangre de drago). Generic drug applicants should use the same plant species and perform BRM assessment: 1. Crofelemer BRM should be collected from the crude red latex of Croton lechleri. The plant species should be correctly identified and authenticated based on techniques such as macroscopic/microscopic and/or analysis of genetic material. 2. Crude red latex as BRM should be collected from the mature tree with defined eco- geographic regions (EGRs). Implementing and enforcing established good agricultural and collection practice (GACP) procedures will minimize variations in BRM and ensure batch- to-batch consistency of crofelemer. 3. BRMs should be analyzed for their crofelemer content, total phenolics and taspine content, as well as heavy metals and pesticides. Recommendations for Demonstrating API Sameness: API sameness can be established by showing equivalence between Test API and API from the reference listed drug (RLD) product with the three criteria described in detail below. -
Supplementary Information
Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262 -
Where Do We Stand After Decades of Studying Human Cytomegalovirus?
microorganisms Review Where do we Stand after Decades of Studying Human Cytomegalovirus? 1, 2, 1 1 Francesca Gugliesi y, Alessandra Coscia y, Gloria Griffante , Ganna Galitska , Selina Pasquero 1, Camilla Albano 1 and Matteo Biolatti 1,* 1 Laboratory of Pathogenesis of Viral Infections, Department of Public Health and Pediatric Sciences, University of Turin, 10126 Turin, Italy; [email protected] (F.G.); gloria.griff[email protected] (G.G.); [email protected] (G.G.); [email protected] (S.P.); [email protected] (C.A.) 2 Complex Structure Neonatology Unit, Department of Public Health and Pediatric Sciences, University of Turin, 10126 Turin, Italy; [email protected] * Correspondence: [email protected] These authors contributed equally to this work. y Received: 19 March 2020; Accepted: 5 May 2020; Published: 8 May 2020 Abstract: Human cytomegalovirus (HCMV), a linear double-stranded DNA betaherpesvirus belonging to the family of Herpesviridae, is characterized by widespread seroprevalence, ranging between 56% and 94%, strictly dependent on the socioeconomic background of the country being considered. Typically, HCMV causes asymptomatic infection in the immunocompetent population, while in immunocompromised individuals or when transmitted vertically from the mother to the fetus it leads to systemic disease with severe complications and high mortality rate. Following primary infection, HCMV establishes a state of latency primarily in myeloid cells, from which it can be reactivated by various inflammatory stimuli. Several studies have shown that HCMV, despite being a DNA virus, is highly prone to genetic variability that strongly influences its replication and dissemination rates as well as cellular tropism. In this scenario, the few currently available drugs for the treatment of HCMV infections are characterized by high toxicity, poor oral bioavailability, and emerging resistance. -
5 Oligonucleotide Applications for the Therapy And
Please use AdobeAcrobat Acrobat isSecuring blocking Reader Connection... documentloading.com to read this book chapter for free. Just open this same document with Adobe Reader. If you do not have it, youor can download it here. You can freely access the chapter at the Web Viewer here. We areFile cannotIntechOpen, be found. the world’s leading publisher of Open Access books Built by scientists, for scientists 5,400 133,000 165M Open access books available International authors and editors Downloads Our authors are among the 154 TOP 1% 12.2% Countries delivered to most cited scientists Contributors from top 500 universities Selection of our books indexed in the Book Citation Index in Web of Science™ Core Collection (BKCI) Interested in publishing with us? Contact [email protected] Numbers displayed above are based on latest data collected. For more information visit www.intechopen.com Please use AdobeAcrobat Acrobat isSecuring blocking Reader Connection... documentloading.com to read this book chapter for free. Just open this same document with Adobe Reader. If you do not have it, youor can download it here. You can freely access the chapter at the Web Viewer here. File cannot be found. 5 Oligonucleotide Applications for the Therapy and Diagnosis of Human Papillomavirus Infection María L. Benítez-Hess, Julia D. Toscano-Garibay and Luis M. Alvarez-Salas* Laboratorio de Terapia Génica, Departamento de Genética y Biología Molecular, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, México D.F. México 1. Introduction Cervical cancer is the best known example of a common human malignancy with a proven infectious etiology. -
Biotechnology INITIATION REPORT Member FINRA/SIPC
INSTITUTIONAL RESEARCH Biotechnology INITIATION REPORT Member FINRA/SIPC Toll-Free: 561-391-5555 ⬧ www.DawsonJames.com ⬧ 1 North Federal Highway - Suite 500 ⬧ Boca Raton, FL 33432 Jaguar (NASDAQ/JAGX) January 3, 2019 BUY It’s Time for a Natural Solution Jason H. Kolbert Head of Healthcare Research 646-465-6891 It's time for a natural solution. Crofelemer, brand name Mytesi, is a natural product derived from an abundant source, the Corton lechleri tree. It treats diarrhea at its [email protected] source by normalizing secretion of water into the gut. Mytesi is the only FDA approved antisecretory diarrhea treatment on the market today. Investment Highlights Current Price $0.28 Mytesi revenues are starting to build, reflecting Jaguar's focused product launch Price Target $1.00 efforts. Chronic diarrhea is a common side-effect of HIV therapy and annually Estimates F2017A F2018E F2019E impacts greater than 250,000 people in the U.S. Jaguar is looking to address this Revenues ($000s) $ 4,361 $ 4,620 $ 16,054 population with a new salesforce that is now actively promoting the drug. Sales growth 1Q March $ 822 $ 804 $ 2,482 since promotion efforts began in 2017 looks favorable. We estimate Mytesi could 2Q June $ 897 $ 884 $ 3,085 3Q September $ 1,100 $ 1,132 $ 4,542 reach $4.4M in revenues this year, $15.7M in 2019, and $28.7M in 2020, driving the 4Q December $ 1,542 $ 1,800 $ 5,946 company to break-even. We estimate that by 2028 Mytesi in HIV alone can reach F2017A F2018E F2019E $76M in revenues, which would represent less than 10% of the total HIV market. -
Compare and Contrast: IBS/IBD Irritable Bowel Syndrome: Diagnosis
Irritable Bowel Syndrome: Treatment Disclosure Overview Focusing on Newly Approved Medications • I, or an immediate family member, including spouse or partner, have no financial relationship(s) relevant to the contents of this Southwest Florida Society of Health System Pharmacists continuing education activity Jose Barboza, Pharm.D., C.D.E. Faculty Pharmacotherapeutics & Clinical Research University of South Florida College of Pharmacy Objectives Irritable Bowel Syndrome: Definition • Gastrointestinal (GI) syndrome 1. Describe the pathophysiology of Irritable – Altered bowel function – Abdominal pain or discomfort Bowel Syndrome • Diarrhea predominant – Altered bowel habits (IBS‐D) 2. Review the treatments for Irritable Bowel – Absence of organic cause • Constipation Syndrome • Recurring symptoms predominant (IBS‐C) – Incomplete evacuation • Constipation/ diarrhea 3. Discuss the use of rifaximin and – Urgency (IBS‐M) eluxadoline in treating diarrhea – Bloating • Undefined (IBS‐U) predominant irritable bowel syndrome Compare and Contrast: IBS/IBD Irritable Bowel Syndrome: Diagnosis Irritable Bowel Inflammatory Bowel Rome III Criteria for Irritable Bowel Syndrome Syndrome (IBS) Disease (IBD) Recurrent abdominal pain or discomfort Three episodes per month Pain/ Discomfort Last 3 months associated Chronic inflammation Change in Bowel habits Two or more of… of the intestines Absence of organic cause 1 Improvement with defecation 2 Onset associated with change in frequency of stool Diarrhea (IBS‐D) Crohn’s disease (CD) Constipation (IBS‐C) -
Federal Register/Vol. 85, No. 224/Thursday, November 19, 2020/Notices PRODUCTS—Continued
73726 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices information on the cover sheet and not guidances are posted on FDA’s website TABLE 2—REVISED DRAFT PRODUCT- in the body of your comments and you and announced periodically in the SPECIFIC GUIDANCES FOR DRUG must identify this information as Federal Register. The public is PRODUCTS—Continued ‘‘confidential.’’ Any information marked encouraged to submit comments on as ‘‘confidential’’ will not be disclosed those recommendations within 60 days Active ingredient(s) except in accordance with 21 CFR 10.20 of their announcement in the Federal and other applicable disclosure law. For Register. FDA considers any comments Fluphenazine hydrochloride more information about FDA’s posting received and either publishes final Hydrocortisone acetate of comments to public dockets, see 80 guidances or publishes revised draft Isotretinoin (multiple referenced listed drugs) Levorphanol tartrate FR 56469, September 18, 2015, or access guidances for comment. Guidances were Lomitapide mesylate the information at: https:// last announced in the Federal Register Methylphenidate hydrochloride www.govinfo.gov/content/pkg/FR-2015- on August 26, 2020. This notice Pimavanserin tartrate 09-18/pdf/2015-23389.pdf. announces draft product-specific Propranolol hydrochloride (multiple ref- Docket: For access to the docket to guidances, either new or revised, that erenced listed drugs) read background documents or the are posted on FDA’s website. Tofacitinib citrate electronic and written/paper comments II. Drug Products For Which New Draft received, go to https:// For a complete history of previously Product-Specific Guidances Are www.regulations.gov and insert the published Federal Register notices Available docket number, found in brackets in the related to product-specific guidances, go heading of this document, into the FDA is announcing the availability of to https://www.regulations.gov and ‘‘Search’’ box and follow the prompts new draft product-specific guidances for enter Docket No. -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
Mississippi Division of Medicaid Universal Preferred Drug List
MISSISSIPPI DIVISION OF MEDICAID EFFECTIVE 01/01/2021 UNIVERSAL PREFERRED DRUG LIST Version 2021.13a Updated: 8-30-2021 (For All Medicaid, MSCAN and CHIP Beneficiaries) Conduent’s SmartPA Pharmacy Application (SmartPA) is a proprietary electronic prior authorization system used for Medicaid fee for service claims. MSCAN plans may/may not -have electronic PA functionality. However, they must adhere to Medicaid’s PA criteria. THERAPEUTIC PREFERRED AGENTS NON-PREFERRED AGENTS PA CRITERIA DRUG CLASS ACNE AGENTS ANTI-INFECTIVE clindamycin gel (generic Cleocin-T) ACZONE (dapsone) Maximum Age Limit clindamycin lotion AKNE-MYCIN (erythromycin) • 21 years – all agents except clindamycin solution azelaic acid isotretinoins AMZEEQ FOAM (minocycline) AZELEX (azelaic acid) CLEOCIN-T (clindamycin) CLINDAMYCIN PAC (clindamycin) CLINDAGEL (clindamycin) clindamycin foam clindamycin gel daily (generic Clindagel) dapsone ERY (erythromycin) ERYGEL (erythromycin) erythromycin gel, swabs, solution EVOCLIN (clindamycin) KLARON (sulfacetamide) sulfacetamide RETINOIDS RETIN-A (tretinoin) adapalene tretinoin cream AKLIEF (trifarotene) ALTRENO (tretinoin) ARAZLO (tazarotene) ATRALIN (tretinoin) AVITA (tretinoin) DIFFERIN (adapalene) FABIOR (tazarotene) PLIXDA (adapalene) 1 Drug coverage subject to the rules and regulations set forth in Sec. 1927 of Social Security Act.This is not an all-inclusive list of available covered drugs and includes only managed categories. Unless otherwise stated, the listing of a particular brand or generic name includes all dosage forms of that drug. NR indicates a new drug that has not yet been reviewed by the P&T Committee. PREFERRED BRANDS will not count toward the two brand monthly Rx limit. Drugs highlighted in yellow denote a change in PDL status. An * denotes existing users will be grandfathered; grandfathering is defined as approving a Non-Preferred agent for an existing user; all other changes will not qualify for grandfathering. -
Quantity Limit Drugs and Diabetic Supplies
Quantity Limit Drugs and Diabetic Supplies Effective 2/1/2015 Class and Name Effective Date ALLERGEN EXTRACTS, GRASS POLLEN 34 Per Month Quantity Limit Grastek 7/1/2014 Oralair 9/26/2014 ALLERGEN EXTRACTS, RAGWEED 34 Per Month Quantity Limit Ragwitek 7/1/2014 ALZHEIMER'S AGENTS 34 Per Month Quantity Limit memantine 7 mg er 6/1/2013 memantine 14 mg er 6/1/2013 memantine 21 mg er 6/1/2013 memantine 28 mg er 6/1/2013 memantine er starter pack 6/1/2013 68 Per Month Quantity Limit memantine 5 mg 6/1/2013 memantine 10 mg 6/1/2013 memantine starter pack 6/1/2013 ANALGESICS/ANESTHETICS, TOPICAL 90 Patches Per Month Quantity Limit lidocaine topical 5% patch 10/1/2010 ANALGESICS, OPIOIDS, LONG-ACTING 4 Per Month Quantity Limit buprenorphine transderm 5 mcg/hr patch 2/1/2011 buprenorphine transderm 7.5 mcg/hr patch 10/1/2014 buprenorphine transderm 10 mcg/hr patch 2/1/2011 buprenorphine transderm 15 mcg/hr patch 10/1/2013 buprenorphine transderm 20 mcg/hr patch 2/1/2011 34 Per Month Quantity Limit Hydrocodone Products hydrocodone 20 mg er tab 1/1/2015 hydrocodone 30 mg er tab 1/1/2015 hydrocodone 40 mg er tab 1/1/2015 hydrocodone 60 mg er tab 1/1/2015 hydrocodone 80 mg er tab 1/1/2015 hydrocodone 100 mg er tab 1/1/2015 hydrocodone 120 mg er tab 1/1/2015 Tramadol Products tramadol 200 mg er 10/1/2011 tramadol 200 mg sr 9/1/2010 Page 1 of 16 Class and Name Effective Date ANALGESICS, OPIOIDS, LONG-ACTING (Continued) 34 Per Month Quantity Limit (Continued) Tramadol Products (Continued) tramadol 300 mg er 10/1/2011 tramadol 300 mg sr 9/1/2010 68 Per -
Drugs/Medications Known to Cause Diaphoresis
Drugs/Medications Known to Cause Diaphoresis Certain prescription and non-prescription medications can cause diaphoresis (excess perspiration or sweating) as a side effect. A list of potentially sweat-inducing medications is provided below. Medications are listed alphabetically by generic name. U.S. brand names are given in parentheses, if applicable. This list is provided as a resource and a service. It is not exhaustive and is in no way meant to replace consultation with a medical professional. Although sweating is a known side effect of the medications listed below, in most cases only a small percentage of people using the medicines experience undue sweating (in some cases less than 1%). Medications noted with an “*” are the most likely to cause sweating and the frequency of sweating as a side effect from these medications may be as high as 50%. Abciximab (ReoPro®) Acamprosate (Campral®) Acetaminophen and Tramadol (Ultracet™) Acetophenazine (NA) Acetylcholine (Miochol-E®) Acetylcysteine (Acetadote®) Acitretin (Soriatane®) Acrivastine and Pseudoephedrine (Semprex®-D) Acyclovir (Zovirax®) Adenosine (Adenocard®; Adenoscan®) Alemtuzumab (Campath®) Almotriptan (Axert™) Alosetron (Lotronex®) Ambenonium (Mytelase®) Amitriptyline (Elavil®) Amlodipine (Norvasc®) Amoxapine (NA) Amphotericin B (Liposomal) (AmBisome®) Anastrozole (Arimidex®) Anidulafungin (Eraxis™) Antihemophilic Factor (Recombinant) (Advate; Helixate® FS; Kogenate® FS; Recombinate™; ReFacto®) Antithymocyte Globulin (Equine) (Atgam®) Antithymocyte Globulin (Rabbit) (Thymoglobulin®) -
Treatment of AIDS and HIV-Related Conditions: 2001 J Am Board Fam Pract: First Published As on 1 July 2001
Current Report—HIV Treatment of AIDS and HIV-Related Conditions: 2001 J Am Board Fam Pract: first published as on 1 July 2001. Downloaded from Ronald H. Goldschmidt, MD, and Betty J. Dong, PharmD Managing human immunodeficiency virus (HIV) offer the best opportunity to provide comprehen- disease and the acquired immunodeficiency syn- sive care. drome (AIDS) has become more standardized yet This Current Report—HIV updates our annual more complex during the past year. Antiretroviral treatment guidelines.3 These recommendations treatment guidelines now represent a general con- (Table 1) are based on our experience at San Fran- sensus on basic treatment principles and options1 as cisco General Hospital, published guidelines, a re- benefits and risks of therapy have become more view of the medical literature, and experience evident. Clinical manifestations of HIV infection, gained from answering telephone calls to our Na- prognosis, and quality of life are clearly improved tional HIV Telephone Consultation Service for most patients receiving potent antiretroviral (Warmline). Because HIV management changes therapy, yet viral resistance and chronic and short- rapidly, clinicians are advised to refer to the excel- term drug toxicities remain major problems. The lent federal guidelines for the use of antiretroviral markedly decreased incidence of opportunistic in- agents in HIV-infected adults and adolescents1 and fections among treated patients has made unusual for prevention of opportunistic infections,4 which infections less common in daily HIV management. are updated frequently on the Internet (Table 2). The role of resistance assays in HIV care is still These and other federal guidelines are available at being assessed, but they offer great possibilities for http://www.hivatis.org.