CDER New: 6/30/2021

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 June 29, 2021 Assessment of the Use of Patient Experience Data in Regulatory Decision-Making Drugs@FDA Data Files (updated) FDA Drug Shortages Dimercaprol (Bal in Oil) Injection (Updated - Resolved) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Hydralazine Hydrochloride Injection (Updated - Resolved) Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage) Tipranavir Oral Solution (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. June 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Sprycel NDA #021986 Dasatinib Tablet; Oral SUPPL-25 Bristol Myers Squibb Labeling Approved Symjepi NDA #207534 Epinephrine Solution; Intramuscular, Subcutaneous SUPPL-12 Adamis Pharms Corp Labeling Approved Symjepi NDA #207534 Epinephrine Solution; Intramuscular, Subcutaneous SUPPL-12 Adamis Pharms Corp Labeling Approved Symjepi NDA #207534 Epinephrine Solution; Intramuscular, Subcutaneous SUPPL-12 Adamis Pharms Corp Labeling Approved June 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Astepro NDA #022203 Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-18 Mylan Speciality Lp Labeling Approved Astepro NDA #022203 Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-18 Mylan Speciality Lp Labeling Approved Aveed NDA #022219 Testosterone Undecanoate Injectable; Intramuscular SUPPL-16 Endo Pharms Inc REMS Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-108 Merck Sharp Dohme Labeling Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-108 Merck Sharp Dohme Labeling Approved Nerlynx NDA #208051 Neratinib Maleate Tablet; Oral SUPPL-9 Puma Biotech Efficacy Approved Symtuza NDA #210455 Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-17 Janssen Prods Labeling Approved Adhansia Xr NDA #212038 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-2 Purdue Pharma Lp Efficacy Approved Erythromycin ANDA #213628 Erythromycin Tablet; Oral ORIG-1 Orange   Approved Clindamycin Phosphate ANDA #214526 Clindamycin Phosphate Lotion; Topical ORIG-1 Taro Pharms   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