CDER New: 4/29/2021

What's New Related to Drugs Updated Monday through Friday: Drug Firm Annual Registration Status Drug Firm Annual Registration Status Download File National Drug Code Directory NDC Unfinished Drugs Excluded Database File NDC Database Excluded Packages and Products Wholesale Distributor and Third-Party Logistics Providers Reporting April 28, 2021 Tainted Sexual Enhancement Products (updated) CDER Impact Stories: How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products FDA Drug Shortages Atazanavir Capsules (New - Discontinuation) Dexmedetomidine Injection (Updated - Currently in Shortage) Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage) Recent New and Generic Drug Approvals This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. April 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan-Demi NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan-Demi NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Synalgos-Dc NDA #011483 Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-34 Sun Pharm Industries Labeling Approved Synalgos-Dc NDA #011483 Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-34 Sun Pharm Industries Labeling Approved Equagesic NDA #011702 Aspirin; Meprobamate Tablet; Oral SUPPL-40 Sun Pharm Industries Labeling Approved Norgesic NDA #013416 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-30 Medicis Labeling Approved Norgesic Forte NDA #013416 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-30 Medicis Labeling Approved Ponstel NDA #015034 Mefenamic Acid Capsule; Oral SUPPL-45 Avion Pharms Labeling Approved Indocin NDA #016059 Indomethacin Capsule; Oral SUPPL-101 Egalet Labeling Approved Fiorinal NDA #017534 Aspirin; Butalbital; Caffeine Capsule; Oral SUPPL-74 Allergan Labeling Approved Fiorinal NDA #017534 Aspirin; Butalbital; Caffeine Tablet; Oral SUPPL-74 Allergan Labeling Approved Naprosyn NDA #017581 Naproxen Tablet; Oral SUPPL-115 Atnahs Pharma Us Labeling Approved Nalfon NDA #017604 Fenoprofen Calcium Capsule; Oral SUPPL-51 Xspire Pharma Labeling Approved Nalfon NDA #017604 Fenoprofen Calcium Capsule; Oral SUPPL-51 Xspire Pharma Labeling Approved Indocin NDA #017814 Indomethacin Suppository; Rectal SUPPL-44 Egalet Labeling Approved Feldene NDA #018147 Piroxicam Capsule; Oral SUPPL-50 Pfizer Labeling Approved Anaprox NDA #018164 Naproxen Sodium Tablet; Oral SUPPL-65 Atnahs Pharma Us Labeling Approved Anaprox Ds NDA #018164 Naproxen Sodium Tablet; Oral SUPPL-65 Atnahs Pharma Us Labeling Approved Indocin Sr NDA #018185 Indomethacin Capsule, Extended Release; Oral SUPPL-58 Egalet Labeling Approved Indocin NDA #018332 Indomethacin Suspension; Oral SUPPL-42 Egalet Labeling Approved Indomethacin NDA #018829 Indomethacin Capsule; Oral SUPPL-23 Chartwell Molecules Labeling Approved Indomethacin NDA #018829 Indomethacin Capsule; Oral SUPPL-23 Chartwell Molecules Labeling Approved Daypro NDA #018841 Oxaprozin Tablet; Oral SUPPL-33 Pfizer Labeling Approved Indomethacin NDA #018851 Indomethacin Capsule; Oral SUPPL-28 Heritage Labeling Approved Indomethacin NDA #018851 Indomethacin Capsule; Oral SUPPL-28 Heritage Labeling Approved Indomethacin NDA #018858 Indomethacin Capsule; Oral SUPPL-47 Mylan Labeling Approved Naprosyn NDA #018965 Naproxen Suspension; Oral SUPPL-27 Atnahs Pharma Us Labeling Approved Voltaren NDA #019201 Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-48 Novartis Labeling Approved Fiorinal W/Codeine NDA #019429 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-44 Allergan Labeling Approved Fiorinal W/Codeine NDA #019429 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-45 Allergan Labeling Approved Ec-Naprosyn NDA #020067 Naproxen Tablet, Delayed Release; Oral SUPPL-24 Atnahs Pharma Us Labeling Approved Cataflam NDA #020142 Diclofenac Potassium Tablet; Oral SUPPL-29 Novartis Labeling Approved Voltaren-Xr NDA #020254 Diclofenac Sodium Tablet, Extended Release; Oral SUPPL-30 Novartis Labeling Approved Naprelan NDA #020353 Naproxen Sodium Tablet, Extended Release; Oral SUPPL-38 Almatica Labeling Approved Naprelan NDA #020353 Naproxen Sodium Tablet, Extended Release; Oral SUPPL-38 Almatica Labeling Approved Arthrotec NDA #020607 Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-38 Pfizer Labeling Approved Daypro Alta NDA #020776 Oxaprozin Potassium Tablet; Oral SUPPL-10 Pfizer Labeling Approved Mobic NDA #020938 Meloxicam Tablet; Oral SUPPL-28 Boehringer Ingelheim Labeling Approved Celebrex NDA #020998 Celecoxib Capsule; Oral SUPPL-56 Upjohn Labeling Approved Celebrex NDA #020998 Celecoxib Capsule; Oral SUPPL-56 Upjohn Labeling Approved Solaraze NDA #021005 Diclofenac Sodium Gel; Topical SUPPL-22 Fougera Pharms Labeling Approved Novolog Mix 70/30 BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Flexpen BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Flexpen BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Penfill BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Penfill BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Flector NDA #021234 Diclofenac Epolamine System; Topical SUPPL-19 Inst Biochem Labeling Approved Mobic NDA #021530 Meloxicam Suspension; Oral SUPPL-17 Avondale Pharms Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-18 Currax Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-17 Currax Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-18 Currax Labeling Approved Cambia NDA #022165 Diclofenac Potassium For Solution; Oral SUPPL-13 Assertio Labeling Approved Cambia NDA #022165 Diclofenac Potassium For Solution; Oral SUPPL-14 Assertio Labeling Approved Zyprexa Relprevv NDA #022173 Olanzapine Pamoate Suspension, Extended Release; Intramuscular SUPPL-39 Eli Lilly Co REMS Approved Caldolor NDA #022348 Ibuprofen Solution; Intravenous SUPPL-18 Cumberland Pharms Labeling Approved Sprix NDA #022382 Ketorolac Tromethamine Spray, Metered; Nasal SUPPL-21 Zyla Labeling Approved Natroba NDA #022408 Spinosad Suspension; Topical SUPPL-10 Parapro Llc Efficacy Approved Vimovo NDA #022511 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-26 Horizon Labeling Approved Duexis NDA #022519 Famotidine; Ibuprofen Tablet; Oral SUPPL-13 Horizon Labeling Approved Duexis NDA #022519 Famotidine; Ibuprofen Tablet; Oral SUPPL-13 Horizon Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5182 Genzyme Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5182 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5182 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5182 Genzyme Labeling Approved Injectafer NDA #203565 Ferric Carboxymaltose Solution; Intravenous SUPPL-14 Am Regent Efficacy Approved Zorvolex NDA #204592 Diclofenac Capsule; Oral SUPPL-13 Zyla Labeling Approved Pennsaid NDA #204623 Diclofenac Sodium Solution; Topical SUPPL-11 Horizon Labeling Approved Tivorbex NDA #204768 Indomethacin Capsule; Oral SUPPL-8 Genus Labeling Approved Tivorbex NDA #204768 Indomethacin Capsule; Oral SUPPL-8 Genus Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-7 Genus Lifesciences Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-7 Genus Lifesciences Labeling Approved Licart NDA #206976 Diclofenac Epolamine System; Topical SUPPL-7 Ibsa Inst Bio Labeling Approved Vivlodex NDA #207233 Meloxicam Capsule; Oral SUPPL-4 Zyla Labeling Approved Anjeso NDA #210583 Meloxicam Solution; Intravenous SUPPL-1 Baudax Labeling Approved Qmiiz Odt NDA #211210 Meloxicam Tablet, Orally Disintegrating; Oral SUPPL-2 Tersera Labeling Approved Qmiiz Odt NDA #211210 Meloxicam Tablet, Orally Disintegrating; Oral SUPPL-2 Tersera Labeling Approved Elyxyb NDA #212157 Celecoxib Solution; Oral SUPPL-2 Dr Reddys Labeling Approved Elyxyb NDA #212157 Celecoxib Solution; Oral SUPPL-2 Dr Reddys Labeling Approved April 27, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Miralax NDA #022015 Polyethylene Glycol 3350 For Solution; Oral SUPPL-40 Bayer Healthcare Llc Labeling Approved Vilazodone Hydrochloride ANDA #208209 Vilazodone Hydrochloride Tablet; Oral ORIG-1 Accord Hlthcare   Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA