Drug Pipeline Update
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- Candace Merritt
- 6 years ago
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1 CLINICAL SOLUTIONS Drug Insights > December 2015 Drug Pipeline Update New Drug Information Narcan (naloxone): Adapt Pharma and Lightlake Therapeutics received Food and Drug Administration (FDA) approval for their nasally administered naloxone for administration by non-medically trained personnel for treatment of opioid overdose. Basaglar (insulin glargine): The FDA approved Lilly s Basaglar, basal insulin, for the treatment of diabetes. Because of a settlement agreement, the drug is not anticipated to launch until December QuilliChew ER (methylphenidate extended-release): Pfizer received approval for their long-acting, chewable formulation of methylphenidate for the treatment of attention deficit-hyperactivity disorder (ADHD) in patients 6 and older. Generic Drug Information Zyvox (linezolid suspension): There is now a generic version of Pfizer s Zyvox for the treatment of different types of bacterial infections. Jalyn (dutasteride/tamsulosin): GlaxoSmithKline s Jalyn, a treatment for benign prostatic hyperplasia (BPH), is now available generically. Prandimet (repaglinide/metformin): A generic version of NovoNordisk s combination diabetes drug, Prandimet, is now available. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.
2 Drug Insights > Drug Pipeline Update Page 2 New Molecular Entity Approvals in the Past Twelve Months Generic Name Brand Name Manufacturer Indication(s) Date Approved* glycopyrronium glycopyrronium/indacaterol Seebri Neohaler Utibron Neohaler Novartis COPD November 2015 Novartis COPD November 2015 patiromer Veltassa Relypsa High potassium October 2015 insulin degludec/insulin aspart Ryzodeg Novo Nordisk Diabetes October 2015 insulin degludec Tresiba Novo Nordisk Diabetes October 2015 cariprazine Vraylar Allergan Bipolar and schizophrenia September 2015 rolapitant Varubi Tesaro Prevention and treatment of chemotherapy induced nausea and vomiting flibanserin Addyi Sprout Pharmaceuticals Hypoactive sexual desire disorder (women) September 2015 August 2015 sacubitril/valsartan Entresto Novartis Heart failure July 2015 brexpiprazole Rexulti Otsuka/Lundbeck Schizophrenia/depression July 2015 eluxadoline Viberzi Actavis Irritable bowel syndrome with diarrhea ivabradine Corlanor Amgen Heart failure April 2015 isavuconazonium Cresemba Astellas Broad-spectrum azole antifungal March 2015 ceftazidine/avibactam Avycaz Actavis/AstraZeneca Antibiotic February 2015 edoxaban Savaysa Daiichi Sankyo Anticoagulant January 2015 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer.
3 Drug Insights > Drug Pipeline Update Page 3 Other New Product Approvals in the Past Twelve Months Generic Name Brand Name Manufacturer Indication(s) Date Approved* methylphenidate extended-release QuilliChew ER Pfizer ADHD December 2015 insulin glargine Basaglar Lilly Diabetes December 2015 naloxone Narcan Adapt Pharma/ Lightlake Therapeutics calcipotriene/betamethasone, aerosol foam Opioid overdose November 2015 Enstilar Leo Pharma Plaque psoriasis November 2015 meloxicam Vivlodex Iroko Pain October 2015 amphetamine Dynavel XR Tris Pharma ADHD October 2015 buprenorphine buccal film Belbuca Endo, Biodelivery Sciences Pain October 2015 aripiprazole lauroxil Aristada Alkermes Schizophrenia October 2015 morphine ER MorphaBond ER Inspirion Delivery Pain (abuse deterrent) October 2015 aspirin, extended-release Durlaza New Haven Pharmaceuticals Cardiovascular prevention September 2015 empagliflozin and metformin Synjardy Boehringer Ingelheim Diabetes August 2015 levetiracetam Spritam Aprecia Seizures August 2015 tacrolimus Envarsus XR Veloxis Pharma Prophylaxis of rejection in kidney transplant July 2015 doxycycline hyclate Targadox Journey Medical Corporation Treatment of various infections duloxetine 40 mg Irenka Lupin Pharmaceuticals Major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain olodaterol/tiotropium Stiolto Boehringer Ingelheim COPD May 2015 Respimat paliperidone palmitate Invega Trinza Johnson & Johnson Schizophrenia May 2015 codeine/chlorpheniramine Tuzistra XR Tris Pharma/Vernalis Cough and cold relief May 2015 albuterol Proair RespiClick Teva Asthma April 2015 levetiracetam extended-release tablets Elepsia XR Sun Pharmaceuticals Seizures March 2015 levonorgestrel Liletta Actavis/Medicines 360 Intrauterine contraceptive February 2015 insulin U-300 Toujeo Sanofi Diabetes February 2015 olopatadine ophthalmic solution Pazeo Alcon Ocular allergies February 2015 empagliflozin/linagliptin Glyxambi Boehringer Ingelheim/ Eli Lilly Diabetes January 2015 hydrocodone ER Zohydro ER Zogenix Pain January 2015 perindopril and amlodpine Prestalia Symplmed Pharmaceuticals High blood pressure January 2015 carbidopa/levodopa enteral suspension carbidopa/levodopa extended release Duopa AbbVie Parkinson s disease January 2015 Rytary Impax Laboratories Parkinson s disease January 2015 ivermectin cream 1% Soolontra Galderma Rosacea January 2015 memantine extended release/ donepezil Namzaric Forest Alzheimer s disease January 2015 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product s manufacturer.
4 Drug Insights > Drug Pipeline Update Page 4 Pipeline Watch Generic Name Brand Name Manufacturer Indication(s) Anticipated FDA Decision Date lesinurad N/A AstraZeneca Gout December 2015 gepirone ER N/A Fabre-Kramer Pharmaceuticals oxycodone/naltrexone, extended release Depression 1Q2016 N/A Pfizer Pain January 2016 granisetron, extended release Sustol Heron Therapeutics Nausea/vomiting January 2016 amphetamine, extended release, orally disintegrating NA Neos Therapeutics ADHD January 2016 buprenorphine implant Probuphine Braeburn and Titan Maintenance treatment of opioid dependence February 2016 safinamide Xadago Newron Pharmaceuticals Parkinson s disease March 2016 calcifediol Rayaldee Opko Health Chronic kidney disease and vitamin D insufficiency aripiprazole, digital tablet Abilify Otsuka/Proteus Health Schizophrenia, bipolar disorder and major depression March 2016 April 2016 dronabinol oral solution NA Insys Therapeutics Cachexia April 2016 bromfenac 0.075% BromSite InSite Vision Inflammation and pain associated with cataract surgery April 2016 methylnaltrexone Relistor Valeant Opioid-induced constipation April 2016 pimavanserin Nuplazid Acadia Psychosis associated with Parkinson s disease April 2016
5 Drug Insights > Drug Pipeline Update Page 5 First Generic Approvals of Top Selling Brand Name Drugs in the Past Twelve Months Generic Name Brand Name Brand Manufacturer Indication(s) Date Approved* dutasteride Avodart GlaxoSmithKline BPH October 2015 memantine Namenda Actavis Alzheimer s disease July 2015 glatiramer Glatopa Teva Relapsing-remitting multiple sclerosis aripiprazole Abilify Bristol-Myers Squibb Schizophrenia, bipolar disorder and Tourette s syndrome May 2015 esomeprazole Nexium AstraZeneca Gastrointestinal disorders February 2015 * Date usually indicates FDA approval date. The product s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market.
6 Drug Insights > Drug Pipeline Update Page 6 Other First Generic Approvals in the Past Twelve Months Generic Name Brand Name Brand Manufacturer Indication(s) Date Approved* linezolid suspension Zyvox Pfizer Treatment of bacterial infection December 2015 repaglinide/metformin Prandimet NovoNordisk Diabetes December 2015 dutasteride/tamsulosin Jalyn GlaxoSmithKline BPH December 2015 trimipramine Surmontil Teva Antidepressant November 2015 nevirapine ER Viramune XR Boehringer Ingelheim HIV November 2015 paliperidone ER Invega Janssen Schizophrenia October 2015 fluvastatin Lescol XL Novartis High cholesterol October 2015 testosterone transdermal gel, 1% Androgel AbbVie Low testosterone October 2015 pimozide Orap Teva Tourette s disorder October 2015 methyltestosterone Testred and Valeant Hormone replacement October 2015 Android memantine oral solution Namenda Actavis Alzheimer s disease October 2015 rivastigmine TD patch Exelon TD patch Novartis Alzheimer s disease September 2015 tretinoin gel, 0.05% Atralin Valeant Acne September 2015 naproxen SR 24hr Naprelan SR Almatica and Shionogi Pharma tetrabenazine Xenazine Lundbeck Chorea associated with Huntington s disease Pain September 2015 August 2015 pramipexole extended release Mirapex Boehringer Ingelheim Parkinson s disease August 2015 phenoxybenzamine Dibenzyline Concordia Pheochromocytoma August2015 acetaminophen/caffeine/ dihydrocodeine Trezix Wraser Pharmaceuticals Pain August2015 megestrol acetate suspension Megace ES Par Los of appetite August2015 budesonide inhalation susp, 1 mg/2 ml Pulmicort Respules AstraZeneca Respiratory August2015 almotriptan Axert Jannsen Migraine July 2015 pyridostigmine bromide Mestinon Timespan Valeant Myasthenia gravis July 2015 bexarotene Targretin Valeant Cutaneous T-cell lymphoma July 2015 alosetron Lotronex Prometheus Irritable bowel syndrome with diarrhea naftifine cream, 1% Naftin Merz Fungal infections (topical) risedronate Actonel Actavis Osteoporosis norethindrone/ethinyl estradiol Femhrt Actavis Menopause symptoms May 2015 tolcapone Tasmar Valeant Parkinson s disease May 2015 Continued
7 Drug Insights > Drug Pipeline Update Page 7 Other First Generic Approvals in the Past Twelve Months (Continued) Generic Name Brand Name Brand Manufacturer Indication(s) Date Approved* benzonatate Zonatuss Vertical Cough relief May 2015 metoclopramide ODT Metozolv ODT Salix Gastroesophageal reflux disease April 2015 norethindrone/ethinyl estradiol/fe Generess FE Warner Chilcott Oral contraceptive April 2015 naproxen sustained-release Naprelan Almatica Pain March 2015 methylphenidate chewable tabs Methylin Shionogi Pharma ADHD March 2015 pramipexole Mirapex ER Boehringer Ingelheim Parkinson s disease February 2015 clobetasol spray, 0.05% Clobex spray Galderma Psoriasis January 2015 estradiol TD patch Vivelle Dot Novartis Vasomotor symptoms January 2015 *Date usually indicates FDA approval date. The product s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. Generics of Top Selling Brand Drugs Potentially Available Soon Generic Name Brand Name Brand Manufacturer Indication(s) To Market Date* imatinib Gleevec Novartis Cancer (multiple indications) February 2016 rosuvastatin Crestor AstraZeneca High cholesterol May 2016 olmesartan and olmesartan/hctz Benicar / Benicar HCT *Expected to market dates are predictions made by Prime Therapeutics based on industry information. Daiichi-Sankyo High blood pressure October A1 Prime Therapeutics LLC 12/15
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