CDER New: 10/29/2020

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 October 28, 2020 A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications Drugs@FDA Data Files (updated) FDA Drug Shortages Cefazolin Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Etomidate Injection (Updated - Currently in Shortage) Ketorolac Tromethamine Injection (Updated - Currently in Shortage) Leuprolide Acetate Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Vecuronium Bromide for Injection (Updated - Currently in Shortage) Manual of Policies and Procedures (MAPP) 6701.3 Rev.1 Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry October 27, 2020 Drug Trials Snapshots: VEKLURY FDA Drug Shortages Cysteamine Hydrochloride Ophthalmic Solution (New - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (New - Discontinuation) Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage) Medroxyprogesterone Acetate (Depo-Provera) Injection, Suspension (New - Discontinuation) Methocarbamol Tablet, USP (New - Discontinuation) Midazolam Injection, USP (Updated - Currently in Shortage) Referencing Approved Drug Products in ANDA Submissions Guidance for Industry Referencing Approved Drug Products in ANDA Submissions Guidance for Industry 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. October 27, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Baqsimi NDA #210134 Glucagon Powder; Nasal SUPPL-2 Eli Lilly and Co Labeling Approved Elestrin NDA #021813 Estradiol Gel, Metered; Transdermal SUPPL-7 Mylan Speciality Lp Labeling Approved Elestrin NDA #021813 Estradiol Gel, Metered; Transdermal SUPPL-9 Mylan Speciality Lp Labeling Approved Sklice NDA #202736 Ivermectin Lotion; Topical SUPPL-6 Arbor Pharms Llc Efficacy Approved Zoledronic Acid NDA #203231 Zoledronic Acid Injectable; Intravenous SUPPL-15 Inforlife Labeling Approved Zoledronic Acid NDA #203231 Zoledronic Acid Injectable; Intravenous SUPPL-16 Inforlife Labeling Approved Zoledronic Acid NDA #203231 Zoledronic Acid Injectable; Intravenous SUPPL-17 Inforlife Labeling Approved October 26, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Chlorpromazine Hydrochloride ANDA #214256 Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Sun Pharm   Approved Ramelteon ANDA #213815 Ramelteon Tablet; Oral ORIG-1 Appco   Approved Survanta BLA #020032 Beractant Suspension; Intratracheal SUPPL-46 Abbvie Labeling Approved Survanta BLA #020032 Beractant Suspension; Intratracheal SUPPL-46 Abbvie Labeling Approved Valacyclovir Hydrochloride ANDA #077478 Valacyclovir Hydrochloride Tablet; Oral SUPPL-13 Sandoz Labeling Approved Valacyclovir Hydrochloride ANDA #077478 Valacyclovir Hydrochloride Tablet; Oral SUPPL-13 Sandoz Labeling Approved Xermelo NDA #208794 Telotristat Etiprate Tablet; Oral SUPPL-1 Tersera Labeling 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