CDER New: 8/30/2021

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 August 26, 2021 FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma August 25, 2021 FDA Drug Shortages Atropine Sulfate Injection (Updated - Currently in Shortage) Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage) Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Digoxin Injection (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Furosemide Injection (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage) Imipenem and Cilastatin for Injection (Updated - Currently in Shortage) Ketorolac Tromethamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage) Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage) Midazolam Injection (Updated - Currently in Shortage) Sodium Acetate Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) August 24, 2021 Drugs@FDA Data Files (updated) August 20, 2021 Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins (new) FDA approves nivolumab for adjuvant treatment of urothelial carcinoma Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. 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. August 25, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Proscar NDA #020180 Finasteride Tablet; Oral SUPPL-49 Merck Labeling Approved Nexium NDA #021153 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-56 Astrazeneca Labeling Approved Nexium NDA #021153 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-56 Astrazeneca Labeling Approved Nexium NDA #021957 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-23 Astrazeneca Labeling Approved Nexium NDA #022101 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-20 Astrazeneca Labeling Approved Vectibix BLA #125147 Panitumumab Injectable; Iv (Infusion) SUPPL-210 Amgen Labeling Approved Cyclophosphamide NDA #210735 Cyclophosphamide Solution; Intravenous ORIG-1 Auromedics Pharma Type 5 - New Formulation or New Manufacturer Approved Tibsovo NDA #211192 Ivosidenib Tablet; Oral SUPPL-8 Servier Efficacy Approved Skytrofa BLA #761177 Lonapegsomatropin-Tcgd Injectable; Injection ORIG-1 Acendis Pharma Endocrinology Div A/S Type 1 - New Molecular Entity Approved August 24, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Flolan NDA #020444 Epoprostenol Sodium Injectable; Injection SUPPL-25 Glaxosmithkline Llc Labeling Approved Flolan NDA #020444 Epoprostenol Sodium Injectable; Injection SUPPL-25 Glaxosmithkline Llc Labeling Approved Fluoxetine Hydrochloride ANDA #076024 Fluoxetine Hydrochloride Tablet; Oral SUPPL-5 Fosun Pharma Labeling Approved Linzess NDA #202811 Linaclotide Capsule; Oral SUPPL-18 Allergan Labeling Approved Linzess NDA #202811 Linaclotide Capsule; Oral SUPPL-18 Allergan Labeling Approved Mayzent NDA #209884 Siponimod Fumaric Acid Tablet; Oral SUPPL-6 Novartis Supplement Approved August 23, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Xarelto NDA #022406 Rivaroxaban Tablet; Oral SUPPL-37 Janssen Pharms Labeling Approved Xarelto NDA #022406 Rivaroxaban Tablet; Oral SUPPL-37 Janssen Pharms Labeling Approved Haloperidol Decanoate ANDA #075393 Haloperidol Decanoate Injectable; Injection SUPPL-36 Teva Pharms Usa Labeling Approved Haloperidol Decanoate ANDA #075440 Haloperidol Decanoate Injectable; Injection SUPPL-49 Mylan Labs Ltd Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #201633 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-16 Sun Pharm Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #201633 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-16 Sun Pharm Labeling Approved Zytiga NDA #202379 Abiraterone Acetate Tablet; Oral SUPPL-35 Janssen Biotech Labeling Approved Zytiga NDA #202379 Abiraterone Acetate Tablet; Oral SUPPL-35 Janssen Biotech Labeling Approved Xarelto NDA #202439 Rivaroxaban Tablet; Oral SUPPL-35 Janssen Pharms Efficacy Approved Acyclovir Sodium ANDA #206535 Acyclovir Sodium Injectable; Injection SUPPL-4 Zydus Pharms Labeling Approved Acyclovir Sodium ANDA #206535 Acyclovir Sodium Injectable; Injection SUPPL-4 Zydus Pharms Labeling Approved Korsuva NDA #214916 Difelikefalin Solution; Intravenous ORIG-1 Cara Therapeutics Inc Type 1 - New Molecular Entity Approved Penicillamine ANDA #215409 Penicillamine Capsule; Oral ORIG-1 Aggrega   Approved August 20, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-67 Pharmacia Labeling Approved Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-68 Pharmacia Labeling Approved Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-67 Pharmacia Labeling Approved Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-68 Pharmacia Labeling Approved Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-67 Pharmacia Labeling Approved Somavert BLA #021106 Pegvisomant Injectable; Subcutaneous SUPPL-68 Pharmacia Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-25 Auxilium Pharms Llc Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-34 Auxilium Pharms Llc Labeling Approved Lidocaine Hydrochloride ANDA #088803 Lidocaine Hydrochloride Solution; Topical SUPPL-17 Hikma Pharms Labeling Approved Gvoke Hypopen NDA #212097 Glucagon Solution; Subcutaneous SUPPL-7 Xeris Labeling Approved Gvoke Pfs NDA #212097 Glucagon Solution; Subcutaneous SUPPL-7 Xeris Labeling Approved Amantadine Hydrochloride ANDA #214178 Amantadine Hydrochloride Syrup; Oral ORIG-1 Invatech   Approved Cyanocobalamin ANDA #215046 Cyanocobalamin Injectable; Injection ORIG-1 Xiromed   Approved Succinylcholine Chloride NDA #215143 Succinylcholine Chloride Injectable; Injection ORIG-1 Hikma Pharms Type 5 - New Formulation or New Manufacturer Approved Metolazone ANDA #215184 Metolazone Tablet; Oral ORIG-1 Rubicon   Approved Bortezomib NDA #215441 Bortezomib Unknown ORIG-1 Intas Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval 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