CDER New: 7/30/2021

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 July 29, 2021 Information on Clozapine (update) Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021 (update) Frequently Asked Questions | Clozapine REMS Modification (new) 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. July 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Clozaril NDA #019758 Clozapine Tablet; Oral SUPPL-98 Heritage Life REMS Approved Vyvanse NDA #021977 Lisdexamfetamine Dimesylate Capsule; Oral SUPPL-46 Takeda Pharms Usa Efficacy Approved Zosyn NDA #050684 Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-98 Wyeth Pharms Labeling Approved Zosyn In Plastic Container NDA #050750 Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-45 Wyeth Pharms Labeling Approved Clozapine ANDA #074949 Clozapine Tablet; Oral SUPPL-84 Ivax Sub Teva Pharms REMS Approved Clozapine ANDA #075417 Clozapine Tablet; Oral SUPPL-49 Mylan REMS Approved Clozapine ANDA #075713 Clozapine Tablet; Oral SUPPL-54 Sun Pharm Inds Inc REMS Approved Clozapine ANDA #076809 Clozapine Tablet; Oral SUPPL-47 Ivax Sub Teva Pharms REMS Approved Clozapine ANDA #090308 Clozapine Tablet, Orally Disintegrating; Oral SUPPL-9 Barr Labs Inc REMS Approved Nucala BLA #125526 Mepolizumab Injectable; Subcutaneous Lyophilized Power SUPPL-18 Glaxosmithkline Llc Efficacy Approved Clozapine ANDA #201824 Clozapine Tablet, Orally Disintegrating; Oral SUPPL-15 Mylan REMS Approved Clozapine ANDA #202873 Clozapine Tablet; Oral SUPPL-10 Accord Hlthcare REMS Approved Clozapine ANDA #203039 Clozapine Tablet, Orally Disintegrating; Oral SUPPL-10 Teva Pharms Usa REMS Approved Versacloz NDA #203479 Clozapine Suspension; Oral SUPPL-16 Tasman Pharma REMS Approved Clozapine ANDA #203807 Clozapine Tablet; Oral SUPPL-13 Mayne Pharma REMS Approved Clozapine ANDA #206433 Clozapine Tablet; Oral SUPPL-12 Aurobindo Pharma Ltd REMS Approved Nucala BLA #761122 Mepolizumab Injectable; Subcutaneous SUPPL-6 Glaxosmithkline Efficacy Approved July 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Triamcinolone Acetonide In Absorbase ANDA #089595 Triamcinolone Acetonide Ointment; Topical SUPPL-8 Cmp Pharma Inc Manufacturing (CMC) Approved Botox BLA #103000 Onabotulinumtoxina Vial; Single-Use SUPPL-5320 Allergan Efficacy Approved Botox Cosmetic BLA #103000 Onabotulinumtoxina Vial; Single-Use SUPPL-5320 Allergan Efficacy Approved Nulojix BLA #125288 Belatacept Injectable; Injection SUPPL-101 Bristol Myers Squibb Labeling Approved Soliqua 100/33 BLA #208673 Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-11 Sanofi-Aventis Us Labeling Approved Soliqua 100/33 BLA #208673 Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-11 Sanofi-Aventis Us Labeling Approved Soliqua 100/33 BLA #208673 Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-11 Sanofi-Aventis Us Labeling Approved Vigabatrin ANDA #212626 Vigabatrin For Solution; Oral ORIG-1 Specgx Llc   Approved Ursodiol ANDA #214329 Ursodiol Capsule; Oral ORIG-1 Vgyaan   Approved Semglee BLA #761201 Insulin Glargine-Yfgn Injectable; Injection ORIG-1 Mylan Pharms Inc Type 2 - New Active Ingredient 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