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LGM-Pharma-Regulatory-1527671011
Pipeline Products List Specialty Portfolio Updated Q2 2018 Updated Q2 2018 See below list of newly approved API’s, samples are readily available for your R&D requirements: Inhalation Ophthalmic Transdermal Sublingual Abaloparatide Defibrotide Sodium Liraglutide Rituximab Abciximab Deforolimus Lixisenatide Rivastigmine Aclidinium Bromide Azelastine HCl Agomelatine Alprazolam Abemaciclib Delafloxacin Lumacaftor Rivastigmine Hydrogen Tartrate Beclomethasone Dipropionate Azithromycin Amlodipine Aripiprazole Acalabrutinib Denosumab Matuzumab Rizatriptan Benzoate Budesonide Besifloxacin HCl Apomorphine Eletriptan HBr Aclidinium Bromide Desmopressin Acetate Meloxicam Rocuronium Bromide Adalimumab Difluprednate Memantine Hydrochloride Rolapitant Flunisolide Bimatoprost Clonidine Epinephrine Aflibercept Dinoprost Tromethamine Micafungin Romidepsin Fluticasone Furoate Brimonidine Tartrate Dextromethorphan Ergotamine Tartrate Agomelatine Dolasetron Mesylate Mitomycin C Romosozumab Fluticasone Propionate Bromfenac Sodium Diclofenac Levocetrizine DiHCl Albiglutide Donepezil Hydrochloride Mometasone Furoate Rotigotine Formoterol Fumarate Cyclosporine Donepezil Meclizine Alectinib Dorzolamide Hydrochloride Montelukast Sodium Rucaparib Iloprost Dexamethasone Valerate Estradiol Melatonin Alemtuzumab Doxercalciferol Moxifloxacin Hydrochloride Sacubitril Alirocumab Doxorubicin Hydrochloride Mycophenolate Mofetil Salmeterol Xinafoate Indacaterol Maleate Difluprednate Fingolimod Meloxicam Amphotericin B Dulaglutide Naldemedine Secukinumab Levalbuterol Dorzolamide -
Betamethasone
Betamethasone Background Betamethasone is a potent, long-acting, synthetic glucocorticoid widely used in equine veterinary medicine as a steroidal anti-inflammatory.1 It is often administered intra-articularly for control of pain associated with inflammation and osteoarthritis.2 Betamethasone is a prescription medication and can only be dispensed from or upon the request of a http://en.wikipedia.org/wiki/Betamethasone#/media/File:Betamethasone veterinarian. It is commercially available .png in a variety of formulations including BetaVet™, BetaVet Soluspan Suspension® and Betasone Aqueous Suspension™.3 Betamethasone can be used intra-articularly, intramuscularly, by inhalation, and topically.4 When administered intra-articularly, it is often combined with other substances such as hyaluronan.5 Intra-articular and intramuscular dosages range widely based upon articular space, medication combination protocol, and practitioner preference. Betamethasone is a glucocorticoid receptor agonist which binds to various glucocorticoid receptors setting off a sequence of events affecting gene transcription and the synthesis of proteins. These mechanisms of action include: • Potential alteration of the G protein-coupled receptors to interfere with intracellular signal transduction pathways • Enhanced transcription in many genes, especially those involving suppression of inflammation. • Inhibition of gene transcription – including those that encode pro-inflammatory substances. The last two of these are considered genomic effects. This type of corticosteroid effect usually occurs within hours to days after administration. The genomic effects persist after the concentrations of the synthetic corticosteroid in plasma are no longer detectable, as evidenced by persistent suppression of the normal production of hydrocortisone following synthetic corticosteroid administration.6 When used judiciously, corticosteroids can be beneficial to the horse. -
Protocol Supplementary
Optimal Pharmacological Management and Prevention of Glucocorticoid-Induced Osteoporosis (GIOP) Protocol for a Systematic Review and Network Meta-Analysis Supplementary Materials: Sample Search Strategy Supplementary 1: MEDLINE Search Strategy Database: OVID Medline Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to Present Line 1 exp Osteoporosis/ 2 osteoporos?s.ti,ab,kf. 3 Bone Diseases, Metabolic/ 4 osteop?eni*.ti,ab,kf. 5 Bone Diseases/ 6 exp Bone Resorption/ 7 malabsorption.ti,ab,kf. 8 Bone Density/ 9 BMD.ti,ab,kf. 10 exp Fractures, Bone/ 11 fracture*.ti,ab,kf. 12 (bone* adj2 (loss* or disease* or resorption* or densit* or content* or fragil* or mass* or demineral* or decalcif* or calcif* or strength*)).ti,ab,kf. 13 osteomalacia.ti,ab,kf. 14 or/1-13 15 exp Glucocorticoids/ 16 exp Steroids/ 17 (glucocorticoid* or steroid* or prednisone or prednisolone or hydrocortisone or cortisone or triamcinolone or dexamethasone or betamethasone or methylprednisolone).ti,ab,kf. 18 or/15-17 19 14 and 18 20 ((glucocorticoid-induced or glucosteroid-induced or corticosteroid-induced or glucocorticosteroid-induced) adj1 osteoporos?s).ti,ab,kf. 21 19 or 20 22 exp Diphosphonates/ 23 (bisphosphon* or diphosphon*).ti,ab,kf. 24 exp organophosphates/ or organophosphonates/ 25 (organophosphate* or organophosphonate*).ti,ab,kf. 26 (alendronate or alendronic acid or Fosamax or Binosto or Denfos or Fosagen or Lendrate).ti,ab,kf. 27 (Densidron or Adrovance or Alenotop or Alned or Dronat or Durost or Fixopan or Forosa or Fosval or Huesobone or Ostemax or Oseolen or Arendal or Beenos or Berlex or Fosalen or Fosmin or Fostolin or Fosavance).ti,ab,kf. -
30 Day Change Notice Effective Date
30 Day Change Notice Effective Date: January 1st, 2021 NEW PREFERRED DRUGS THERAPEUTIC CLASS NO PA REQUIRED PREFERRED Central Nervous System (CNS) Agents: Anticonvulsants Clobazam (Generic of Onfi) Central Nervous System (CNS) Agents: Multiple Aubagio EndocrineSclerosis Agents: Osteoporosis-Bone Ossification Forteo Enhancers Gastrointestinal Agents: Anti-Emetics Bonjesta Genitourinary Agents: Benign Prostatic Hyperplasia Alfuzosin (Generic of Uroxatral) Dutasteride (Generic of Avodart) Genitourinary Agents: Electrolyte Depleter Agents Sevelamer (Generic of Renagel and Renvela) Infectious Disease Agents: Antibiotics-Macrolides Eryped Infectious Disease Agents: Antivirals-HIV Atazanavir Sulfate Oral Powder (Generic of Reyataz) Tivicay PD Infectious Disease Agents: Antibiotics-Tetracyclines Vibramycin Suspension (no PA Required for age 12 or under) Ophthalmic Agents: Antibiotics and Antibiotic -Steroid Neomycin/Polymyxin/Bacitracin/Hydrocortisone Ointment Combination Drops and Ointments Ophthalmic Agents: Glaucoma Agents Dorzolamide/Timolol (Generic of Cosopt PF) NEW CLINICAL PA REQUIRED “PREFERRED” DRUGS THERAPEUTIC CLASS CLINICAL PA REQUIRED PREFERRED Blood Formation, Coagulation, and Thrombosis Agents: Corifact Hemophilia Factors Immunomodulator Agents for Systemic Inflammatory Taltz Disease Immunomodulator Agents for Systemic Inflammatory Xeljanz 5mg Disease NEW STEP THERAPY REQUIRED “PREFERRED” THERAPEUTIC CLASS STEP THERAPY REQUIRED “PREFERRED” Central nervous System (CNS) Agents: Anti-Migraine, Aimovig Prophylaxis Treatment Ajovy -
268 Part 522—Implantation Or Injectable Dosage Form
§ 520.2645 21 CFR Ch. I (4–1–18 Edition) (ii) Indications for use. For the control 522.82 Aminopropazine. of American foulbrood (Paenibacillus 522.84 Beta-aminopropionitrile. larvae). 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. (iii) Limitations. The drug should be 522.90a Ampicillin trihydrate suspension. fed early in the spring or fall and con- 522.90b Ampicillin trihydrate powder for in- sumed by the bees before the main jection. honey flow begins, to avoid contamina- 522.90c Ampicillin sodium. tion of production honey. Complete 522.144 Arsenamide. treatments at least 4 weeks before 522.147 Atipamezole. main honey flow. 522.150 Azaperone. 522.161 Betamethasone. [40 FR 13838, Mar. 27, 1975, as amended at 50 522.163 Betamethasone dipropionate and FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, betamethasone sodium phosphate aque- 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, ous suspension. May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 522.167 Betamethasone sodium phosphate 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; and betamethasone acetate. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 522.204 Boldenone. 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, 522.224 Bupivacaine. Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 522.230 Buprenorphine. 34278, June 16, 2015; 81 FR 48702, July 26, 2016] 522.234 Butamisole. 522.246 Butorphanol. § 520.2645 Tylvalosin. 522.275 N-Butylscopolammonium. 522.300 Carfentanil. (a) Specifications. Granules containing 522.304 Carprofen. 62.5 percent tylvalosin (w/w) as 522.311 Cefovecin. -
Product Portfolio
API Product Portfolio Hovione has developed a range of particle engineered Particle Engineered APIs APIs with superior powder properties that will address the challenges of your formulation development. Corticosteroids PRODUCT ROUTE OF CAS CUSTOMIZED REGULATORY ADMINISTRATION NUMBER PARTICLE SIZE STATUS Beclomethasone Dipropionate Anhydrous Inhalation Nasal Oral Topical 5534-09-08 Beclomethasone Dipropionate Monohydrate Inhalation Nasal 77011-63-3 US DMF Betamethasone Acetate Ophtalmic Injectable 987-24-6 US DMF Betamethasone Disodium Phosphate Ophtalmic Injectable Topical 151-73-5 US DMF, JP DMF Fluticasone Furoate Inhalation Nasal 397864-44-7 US DMF CEP, US DMF, JP DMF, Fluticasone Propionate Inhalation Nasal Topical 80474-14-2 CN DMF Halobetasol Propionate Topical 66852-54-8 US DMF Hydrocortisone Aceponate Topical 74050-20-7 ASMF & VMF Mometasone Furoate Anhydrous Inhalation Nasal Topical 83919-23-7 CEP, US DMF, JP DMF Mometasone Furoate Monohydrate Inhalation Nasal 141646-00-6 CEP, US DMF, JP DMF LABA/LAMA PRODUCT ROUTE OF CAS CUSTOMIZED REGULATORY ADMINISTRATION NUMBER PARTICLE SIZE STATUS Aclidinium Bromide Inhalation 320345-99-1 US DMF Glycopyrronium Bromide Inhalation 51186-83-5 US DMF Salmeterol Xinafoate Inhalation 94749-08-3 CEP, US DMF Indacaterol Maleate Inhalation 312753-06-3 DEV Olodaterol Sulphate Inhalation 869477-96-3 DEV Salbutamol Inhalation 18559-94-9 GMP, TECH PACK Tiotropium Bromide Monohydrate Inhalation 136310-93-5 DEV Umeclidinium Bromide Inhalation 869113-09-7 DEV, TECH PACK Vilanterol Trifenatate Inhalation 503070-58-4 GMP, TECH PACK Hovione provides the peace of mind of a high quality Security of supply manufacturer who is a founding member of Rx-360 and has an unblemished regulatory track record. -
Product List
Arena Product List A Cabazitaxel (Under Development) Acebutolol HCl Calcitriol N-Acetyl-L-Asparagine Calcifediol N-Acetyl-L-Aspartic Acid Calcipotriol Monohydrate Acexamic Acid (Upon Request) Canrenoate K Aesculin Canrenone micronised Agomelatine (Under Development) Capecitabine Alfacalcidol Captopril Alimemazine Tartrate Carbamizole Aliskiren Fumarate (Under Development) Carbasalate Calcium Altizide Carbomers Amcinonide Acetyl Thiazolidin Carboxylic Acid Amifostine L-Carnitine Base Amiodarone HCl (Upon Request) Acetyl-L-Carnitine HCl Amisulpride (Upon Request) Acetyl Carnosine Amitriptyline HCl L-Carnosine Apomorphine HCl Cefaclor L-Arginine Base Cefalexin Monohydrate L-Arginine-L-Aspartate Cefamandole Nafate Sterile L-Arginine-L-Glutamate Cefazedone Sodium Sterile Aripiprazole (Under Development) Cefepime HCL Artesunate (Upon Request) Cefmetazole Artemether (Upon Request) Cefmetazole Sodium Sterile Articaine HCl Cefminox Sodium Sterile L-Asparagine Anyhdrous Cefodizime Disodium L-Asparagine Monohydrate Cefodizime Sodium Sterile DL-Aspartic Acid Magnesium Salt Cefotetan DL-Aspartic Acid Magnesium + Potassium Salt Cefotetan Sodium Sterile DL-Aspartic Acid Potassium Salt Cefozopran (Under Development) L-Aspartic Acid Sodium Salt Monohydrate Cefsulodin (Under Development) Atovaquone (Under Development) Cefsulodin Sodium Sterile Azacitidine (Under Development) Cefuroxime Sodium Azathioprine Powder Cefuroxime Sodium Sterile Centella Asiatica Extract B Cephacetrile Sodium Sterile Baclofen Cetirizine HCl Beclomethasone Base Cetrimide Powder -
INTEGRIS Formulary July 2017
INTEGRIS Formulary July 2017 Foreword FORMULARY EXCLUDED THERAPEUTIC DRUG This document represents the efforts of the MedImpact Healthcare Systems THERAPEUTIC DRUGS CLASS Pharmacy and Therapeutics (P & T) and Formulary Committees to provide ALTERNATIVES physicians and pharmacists with a method to evaluate the safety, efficacy and cost- clindamycin/tretinoin, ACNE AGENTS, effectiveness of commercially available drug products. A structured approach to the VELTIN drug selection process is essential in ensuring continuing patient access to rational ZIANA TOPICAL drug therapies. The ultimate goal of the MedPerform Formulary is to provide a morphine sulfate ER process and framework to support the dynamic evolution of this document to guide tablets, oxycodone ANALGESICS, KADIAN prescribing decisions that reflect the most current clinical consensus associated ER, NUCYNTA, NARCOTICS with drug therapy decisions. NUCYNTA ER ANALGESICS, This is accomplished through the auspices of the MedImpact P & T and Formulary BELBUCA BUTRANS PATCH Committees. These committees meet quarterly and more often as warranted to NARCOTICS ensure clinical relevancy of the Formulary. To accommodate changes to this ABSTRAL, document, updates are made accessible as necessary. FENTORA, fentanyl citrate ANALGESICS, LAZANDA, lozenge NARCOTICS As you use this Formulary, you are encouraged to review the information and ONSOLIS, provide your input and comments to the MedImpact P & T and Formulary SUBSYS Committees. immediate-release GRALISE ANTICONVULSANTS The MedImpact P & T -
Re-Evaluated Data of Dissociation Constants of Alendronic, Pamidronic and Olpadronic Acids
Cent. Eur. J. Chem. • 7(1) • 2009 • 8-13 DOI: 10.2478/s11532-008-0099-z Central European Journal of Chemistry Re-evaluated data of dissociation constants of alendronic, pamidronic and olpadronic acids Invited Paper Alexander P. Boichenko1, Vadim V. Markov1, Hoan Le Kong1, Anna G. Matveeva2, Lidia P. Loginova1* 1Department of Chemical Metrology, Kharkov V.N. Karazin National University, 61077 Kharkov, Ukraine. 2A.N. Nesmeyanov Institute of Organoelement Compounds, Russian Academy of Sciences, 119991 Moscow, Russian Federation Received 01 April 2008; Accepted 23 October 2008 Abstract: The dissociation constants of (4-amino-1-hydroxybutylidene)bisphosphonic (alendronic) acid, (3-(dimethylamino)-1- hydroxypropylidene)bisphosphonic (olpadronic) acid and (3-amino-1-hydroxypropylidene)bisphosphonic (pamidronic) acid were obtained in aqueous solutions (0.10 М КСl) and micellar solutions of cetylpyridinium chloride (0.10 М CPC) at 25.0°C. With the exception of the third dissociation constant of alendronic acid, the dissociation constants of alendronic, olpadronic and pamidronic acids in aqueous solutions matched literature data. The possibility of sodium alendronate determination by acid-base titration by NaOH solution was theoretically grounded on the basis of re-evaluated data of alendronic acid dissociation constants. Keywords: Alendronate • Olpadronate, pamidronate, dissociation constant • Micellar media effect © Versita Warsaw and Springer-Verlag Berlin Heidelberg. 1. Introduction spectrometric [12], refractive index [13] and Sodium salts of (4-amino-1-hydroxybutylidene) conductometric [14] detection have been proposed. bisphosphonic (alendronic) acid, (3-(dimethylamino)- The anion-exchange chromatography with refractive 1-hydroxypropylidene)bisphosphonic (olpadronic) acid index detection is recommended by British and (3-amino-1-hydroxypropylidene)bisphosphonic Pharmacopoeia for the determination of sodium (pamidronic) acid are successfully used for the medical alendronate [15]. -
Phvwp Class Review Bisphosphonates and Osteonecrosis of the Jaw (Alendronic Acid, Clodronic Acid, Etidronic Acid, Ibandronic
PhVWP Class Review Bisphosphonates and osteonecrosis of the jaw (alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid), SPC wording agreed by the PhVWP in February 2006 Section 4.4 Pamidronic acid and zoledronic acid: “Osteonecrosis of the jaw has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.” Remaining bisphosphonates: “Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelits) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphophonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphophonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. -
Kentucky Horse Racing Commission Withdrawal Guidelines Thoroughbred; Standardbred; Quarter Horse, Appaloosa, and Arabian KHRC 8-020-2 (11/2018)
Kentucky Horse Racing Commission Withdrawal Guidelines Thoroughbred; Standardbred; Quarter Horse, Appaloosa, and Arabian KHRC 8-020-2 (11/2018) General Notice Unless otherwise specified in these withdrawal guidelines or the applicable regulations and statutes, the following withdrawal guidelines are voluntary and advisory. The guidelines are recommendations based on current scientific knowledge that may change over time. A licensee may present evidence of full compliance with these guidelines to the Kentucky Horse Racing Commission (the “Commission” or “KHRC”) and the stewards as a mitigating factor to be used in determining violations and penalties. These withdrawal interval guidelines assume that administration of medications will be performed at doses that are not greater than the manufacturer’s maximum recommended dosage. Medications administered at dosages above manufacturer’s recommendations, in compounded formulations and/or in combination with other medications and/or administration inside the withdrawal interval may result in test sample concentrations above threshold concentrations that could lead to positive test results and the imposition of penalties. The time of administration of an orally administered substance, for the purposes of withdrawal interval, shall be considered to be the time of complete ingestion of the medication by the horse via eating or drinking. Brand names of medications, where applicable, are listed in parentheses or brackets following the generic name of a drug. In addition to the requirements contained in KRS Chapter 13A, the KHRC shall give notice of an amendment or addition to these withdrawal guidelines by posting the change on the KHRC website and at all Kentucky racetracks at least two weeks before the amendment or addition takes legal effect. -
Printed Formulary Catalog Basic
Scripps Health Formulary July 2016 Foreword Pharmacy and Therapeutics Committee. MedImpact approves such multi- This document represents the efforts of the MedImpact Healthcare Systems source drugs for addition to the MAC list based on the following criteria: Pharmacy and Therapeutics (P & T) and Formulary Committees to provide physicians A multi-source drug product manufactured by at least one (1) nationally and pharmacists with a method to evaluate the safety, efficacy and cost-effectiveness marketed company. of commercially available drug products. A structured approach to the drug selection At least one (1) of the generic manufacturer’s products must have an “A” process is essential in ensuring continuing patient access to rational drug therapies. rating or the generic product has been determined to be unassociated with The ultimate goal of the Portfolio Formulary is to provide a process and framework to efficacy, safety or bioequivalency concerns by the MedImpact P & T support the dynamic evolution of this document to guide prescribing decisions that Committee. reflect the most current clinical consensus associated with drug therapy decisions. Drug product will be approved for generic substitution by the MedImpact P & T Committee. This is accomplished through the auspices of the MedImpact P & T and Formulary Committees. These committees meet quarterly and more often as warranted to ensure This list is reviewed and updated periodically based on the clinical literature and clinical relevancy of the Formulary. To accommodate changes to this document, pharmacokinetic characteristics of currently available versions of these drug updates are made accessible as necessary. products. As you use this Formulary, you are encouraged to review the information and provide If a member or physician requests a brand name product in lieu of an approved your input and comments to the MedImpact P & T and Formulary Committees.