CDER New: 3/1/2022

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 February 28, 2022 FDA Drug Shortages Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (New - Currently in Shortage) Imipramine Tablets (New - Discontinuation) 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. February 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Fluoroplex NDA #016988 Fluorouracil Cream; Topical SUPPL-33 Almirall Labeling Approved Fluoroplex NDA #016988 Fluorouracil Cream; Topical SUPPL-33 Almirall Labeling Approved Fluoroplex NDA #016988 Fluorouracil Cream; Topical SUPPL-33 Almirall Labeling Approved Akten NDA #022221 Lidocaine Hydrochloride Gel; Ophthalmic SUPPL-8 Akorn Labeling Approved Actemra BLA #125276 Tocilizumab Injectable; Injection SUPPL-134 Genentech Efficacy Approved Myalept BLA #125390 Metreleptin Injectable; Injection SUPPL-24 Aegerion Labeling Approved Actemra BLA #125472 Tocilizumab Injectable; Intravenous, Subcutaneous SUPPL-46 Genentech Labeling Approved Actemra BLA #125472 Tocilizumab Injectable; Intravenous, Subcutaneous SUPPL-46 Genentech Labeling Approved Bortezomib NDA #206927 Bortezomib Powder; Intravenous SUPPL-2 Dr Reddys Labs Ltd Labeling Approved Tetracaine Hydrochloride NDA #208135 Tetracaine Hydrochloride Solution; Ophthalmic SUPPL-5 Alcon Labs Labeling Approved Blenrep BLA #761158 Belantamab Mafodotin-Blmf Injectable; Intravenous SUPPL-6 Glaxosmithkline Labeling Approved Blenrep BLA #761158 Belantamab Mafodotin-Blmf Injectable; Intravenous SUPPL-6 Glaxosmithkline Labeling Approved February 25, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Desoxyn NDA #005378 Methamphetamine Hydrochloride Tablet, Extended Release; Oral SUPPL-37 Recordati Rare Labeling Approved Desoxyn NDA #005378 Methamphetamine Hydrochloride Tablet; Oral SUPPL-37 Recordati Rare Labeling Approved Adderall 10 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 12.5 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 15 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 20 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 30 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 5 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Adderall 7.5 NDA #011522 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral SUPPL-44 Teva Womens Labeling Approved Dexedrine NDA #017078 Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-54 Impax Labs Inc Labeling Approved Adderall Xr 10 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Adderall Xr 15 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Adderall Xr 20 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Adderall Xr 25 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Adderall Xr 30 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Adderall Xr 5 NDA #021303 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-36 Takeda Pharms Usa Labeling Approved Vyvanse NDA #021977 Lisdexamfetamine Dimesylate Capsule; Oral SUPPL-48 Takeda Pharms Usa Labeling Approved Mydayis NDA #022063 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-3 Takeda Pharms Usa Labeling Approved Mydayis NDA #022063 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-3 Takeda Pharms Usa Labeling Approved Acuvue Theravision With Ketotifen NDA #022388 Etafilcon A Lens With Ketotifen Solution; Optical SUPPL-1 Johnson and Johnson Vision Care, Inc Type 3 - New Dosage Form Approved Acuvue Theravision With Ketotifen NDA #022388 Etafilcon A Lens With Ketotifen Solution; Optical ORIG-1 Johnson and Johnson Vision Care, Inc Type 3 - New Dosage Form and Type 4 - New Combination Approved Metaxalone NDA #022503 Metaxalone Tablet; Oral SUPPL-1 Primus Pharms Labeling Approved Yervoy BLA #125377 Ipilimumab Injectable; Injection SUPPL-126 Bristol Myers Squibb Labeling Approved Yervoy BLA #125377 Ipilimumab Injectable; Injection SUPPL-127 Bristol Myers Squibb Labeling Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-109 Bristol Myers Squibb Labeling Approved Cystaran NDA #200740 Cysteamine Hydrochloride Solution/Drops; Ophthalmic SUPPL-3 Leadiant Biosci Inc Manufacturing (CMC) Approved Adzenys Er NDA #204325 Amphetamine Suspension, Extended Release; Oral SUPPL-3 Neos Theraps Inc Labeling Approved Adzenys Xr-Odt NDA #204326 Amphetamine Tablet, Orally Disintegrating, Extended Release; Oral SUPPL-8 Neos Theraps Labeling Approved Nuvessa NDA #205223 Metronidazole Gel; Vaginal SUPPL-6 Chemo Research Sl Labeling Approved Nuvessa NDA #205223 Metronidazole Gel; Vaginal SUPPL-6 Chemo Research Sl Labeling Approved Dyanavel Xr NDA #208147 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Suspension, Extended Release; Oral SUPPL-13 Tris Pharma Inc Labeling Approved Vyvanse NDA #208510 Lisdexamfetamine Dimesylate Tablet, Chewable; Oral SUPPL-5 Takeda Pharms Usa Labeling Approved Evekeo Odt NDA #209905 Amphetamine Sulfate Tablet, Orally Disintegrating; Oral SUPPL-2 Arbor Pharms Llc Labeling Approved Dyanavel Xr 10 NDA #210526 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Tablet, Extended Release; Oral SUPPL-3 Tris Pharma Inc Labeling Approved Dyanavel Xr 15 NDA #210526 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Tablet, Extended Release; Oral SUPPL-3 Tris Pharma Inc Labeling Approved Dyanavel Xr 20 NDA #210526 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Tablet, Extended Release; Oral SUPPL-3 Tris Pharma Inc Labeling Approved Dyanavel Xr 5 NDA #210526 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Tablet, Extended Release; Oral SUPPL-3 Tris Pharma Inc Labeling Approved Arakoda NDA #210607 Tafenoquine Succinate Tablet; Oral SUPPL-2 60 Degrees Pharms Manufacturing (CMC) Approved Arakoda NDA #210607 Tafenoquine Succinate Tablet; Oral SUPPL-2 60 Degrees Pharms Manufacturing (CMC) Approved Releuko BLA #761082 Filgrastim-Ayow Injectable; Injection ORIG-1 Kashiv Biosciences Llc Type 5 - New Formulation or New Manufacturer 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