CDER New: 7/1/2022

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 June 30, 2022 Drug Safety Communication: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) 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, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ortikos NDA #211929 Budesonide Capsule, Extended Release; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved Ortikos NDA #211929 Budesonide Capsule, Extended Release; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved Valganciclovir Hydrochloride ANDA #213306 Valganciclovir Hydrochloride For Solution; Oral SUPPL-1 Granules Labeling Approved Valganciclovir Hydrochloride ANDA #213306 Valganciclovir Hydrochloride For Solution; Oral SUPPL-3 Granules Labeling Approved Venbysi Xr NDA #215429 Venlafaxine Besylate Tablet, Extended Release; Oral ORIG-1 Almatica Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approved Venbysi Xr NDA #215429 Venlafaxine Besylate Tablet, Extended Release; Oral ORIG-2 Almatica Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approved Drospirenone NDA #216285 Drospirenone Tablet, Chewable; Oral ORIG-1 Exeltis Usa Inc Type 3 - New Dosage Form Approved June 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Naropin NDA #020533 Ropivacaine Hydrochloride Solution; Injection SUPPL-44 Fresenius Kabi Usa Labeling Approved Nasonex NDA #020762 Mometasone Furoate Spray, Metered; Nasal SUPPL-56 Organon Labeling Approved Nasonex NDA #020762 Mometasone Furoate Spray, Metered; Nasal SUPPL-56 Organon Labeling Approved Nasonex NDA #020762 Mometasone Furoate Spray, Metered; Nasal SUPPL-56 Organon Labeling Approved Kabiven In Plastic Container NDA #200656 Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil Emulsion; Intravenous SUPPL-14 Fresenius Kabi Usa Labeling Approved Perikabiven In Plastic Container NDA #200656 Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil Emulsion; Intravenous SUPPL-14 Fresenius Kabi Usa Labeling Approved Tramadol Hydrochloride ANDA #202075 Tramadol Hydrochloride Tablet; Oral SUPPL-4 Aci Labeling Approved Tramadol Hydrochloride ANDA #202075 Tramadol Hydrochloride Tablet; Oral SUPPL-4 Aci Labeling Approved Cisatracurium Besylate ANDA #203078 Cisatracurium Besylate Injectable; Injection ORIG-1 Hikma   Approved Olmesartan Medoxomil ANDA #204798 Olmesartan Medoxomil Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved Diltiazem Hydrochloride ANDA #211596 Diltiazem Hydrochloride Tablet; Oral SUPPL-1 Edenbridge Pharms Manufacturing (CMC) Approved Diltiazem Hydrochloride ANDA #211596 Diltiazem Hydrochloride Tablet; Oral SUPPL-1 Edenbridge Pharms Manufacturing (CMC) Approved Bupropion Hydrochloride ANDA #215568 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Granules Labeling Approved Bupropion Hydrochloride ANDA #215568 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Granules 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