CDER New: 5/27/2022

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 May 27, 2022 FDA Drug Shortages Iodixanol (Visipaque) Injection (Updated - Currently in Shortage) Iohexol (Omnipaque) Injection (Updated - Currently in Shortage) May 26, 2022 Frequently Asked Questions on Benzene Contamination in Drugs FDA Drug Shortages Iopromide (Ultravist) Injection (New - Currently in Shortage) Varenicline Tartrate (Chantix) Tablets (Updated - Resolved) 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. May 26, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Pemetrexed NDA #214657 Pemetrexed Solution; Injection ORIG-1 Sandoz Inc Type 5 - New Formulation or New Manufacturer Approved Pemetrexed NDA #214657 Pemetrexed Solution; Intravenous ORIG-1 Sandoz Inc Type 5 - New Formulation or New Manufacturer Approved Fylnetra BLA #761084 Pegfilgrastim-Pbbk Injectable; Injection ORIG-1 Kashiv Biosciences Llc Type 2 - New Active Ingredient Approved May 25, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Sucraid BLA #020772 Sacrosidase Solution; Oral SUPPL-27 Qol Medcl Manufacturing (CMC) Approved Zonisamide ANDA #077625 Zonisamide Capsule; Oral SUPPL-8 Cadila Labeling Approved Zonisamide ANDA #077625 Zonisamide Capsule; Oral SUPPL-8 Cadila Labeling Approved Zonisamide ANDA #077634 Zonisamide Capsule; Oral SUPPL-18 Sun Pharm Inds (In) Labeling Approved Zonisamide ANDA #077634 Zonisamide Capsule; Oral SUPPL-18 Sun Pharm Inds (In) Labeling Approved Zonisamide ANDA #077642 Zonisamide Capsule; Oral SUPPL-9 Apotex Inc Labeling Approved Zonisamide ANDA #077651 Zonisamide Capsule; Oral SUPPL-17 Glenmark Generics Labeling Approved Zonisamide ANDA #077869 Zonisamide Capsule; Oral SUPPL-14 Invagen Pharms Labeling Approved Zonisamide ANDA #077869 Zonisamide Capsule; Oral SUPPL-14 Invagen Pharms Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #201356 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-13 Invagen Pharms Labeling Approved Pemetrexed Disodium ANDA #202111 Pemetrexed Disodium Injectable; Injection ORIG-1 Hospira Inc   Approved Pemetrexed Sodium ANDA #202596 Pemetrexed Sodium Unknown ORIG-1 Dr Reddys Labs Ltd   Approved Pemetrexed ANDA #203485 Pemetrexed Disodium Injectable; Injection ORIG-1 Accord Hlthcare Inc   Approved Pemetrexed ANDA #203774 Pemetrexed Unknown ORIG-1 Apotex Inc   Approved Pemetrexed ANDA #204890 Pemetrexed Disodium Powder; Intravenous ORIG-1 Qilu Pharm Co Ltd   Approved Pemetrexed Disodium ANDA #207352 Pemetrexed Disodium Powder; Intravenous ORIG-1 Nang Kuang Pharm Co   Approved Pemetrexed ANDA #208696 Pemetrexed Powder; Intravenous ORIG-1 Jiangsu Hansoh Pharm   Approved Posaconazole ANDA #208768 Posaconazole Unknown ORIG-1 Par Sterile Products   Approved Pemetrexed ANDA #209085 Pemetrexed Unknown ORIG-1 Apotex Inc   Approved Pemetrexed ANDA #209851 Pemetrexed Injectable; Iv (Infusion) ORIG-1 Apotex Inc   Approved Yupelri NDA #210598 Revefenacin Solution; Inhalation SUPPL-3 Mylan Ireland Ltd Labeling Approved Pemetrexed Disodium NDA #211090 Pemetrexed Disodium Powder; Intravenous ORIG-1 Biocon Pharma Ltd   Approved Tibsovo NDA #211192 Ivosidenib Tablet; Oral SUPPL-9 Servier Efficacy Approved Pemetrexed ANDA #211899 Pemetrexed Unknown ORIG-1 Waverley Pharma International Inc   Approved Pemetrexed ANDA #214073 Pemetrexed Disodium Powder; Intravenous ORIG-1 Zydus Pharms Usa Inc   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