US FDA

CDER New: 2/12/2024

US FDA sent this email to their subscribers on February 12, 2024.

ADMINISTRATION RN LR LU

What's New Related to Drugs

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.


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ADMINISTRATION RN LR LU 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 February 9, 2024 * FDA Drug Shortages * Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) * Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage) * Dextrose Monohydrate Injection (Updated - Currently in Shortage) * Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) * Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Updated - Currently in Shortage) * Ketamine Hydrochloride Injection (Updated - Currently in Shortage) * Lidocaine Hydrochloride Injection (Updated - Currently in Shortage) * Lorazepam Injection (Updated - Currently in Shortage) * Mannitol Injection (Updated - Currently in Shortage) * Methotrexate Sodium Injection (Updated - Currently in Shortage) * Midazolam Hydrochloride Injection (Updated - Currently in Shortage) * Potassium Chloride Injection (Updated - Currently in Shortage) * Rocuronium Bromide Injection (Updated - Currently in Shortage) * Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) * Sodium Chloride 14.6% Injection (Updated - Currently in Shortage) * Sodium Chloride 23.4% Injection (Updated - Currently in Shortage) * Sterile Water Injection (Updated - Currently in Shortage) * Orange Book           * Approved Drug Products with Therapeutic Equivalence Evaluations * Orange Book Current Cumulative Supplement (updated) * Additions/Deletions for Prescription and OTC Drug Product Lists (updated) * Orange Book Data Files (compressed) (updated)                   * Reference Listed Drugs by ANDA Reference Standard List (updated) * Orange Book Patent Listing Dispute List (updated) 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. FEBRUARY 9, 2024 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Pulmozyme BLA #103532 Dornase Alfa Vial SUPPL-5194 Genentech Labeling Approved Deflazacort ANDA #217123 Deflazacort Tablet; Oral ORIG-1 Aurobindo Pharma   Approved Sterile Water For Injection ANDA #217341 Sterile Water For Injection Liquid; N/A SUPPL-1 Am Regent Manufacturing (CMC) Approved FEBRUARY 8, 2024 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Tracleer NDA #021290 Bosentan Tablet; Oral SUPPL-44 Actelion Labeling Approved Vytorin NDA #021687 Ezetimibe; Simvastatin Tablet; Oral SUPPL-61 Organon Labeling Approved Vytorin NDA #021687 Ezetimibe; Simvastatin Tablet; Oral SUPPL-64 Organon Labeling Approved Vytorin NDA #021687 Ezetimibe; Simvastatin Tablet; Oral SUPPL-65 Organon Labeling Approved Vytorin NDA #021687 Ezetimibe; Simvastatin Tablet; Oral SUPPL-65 Organon Labeling Approved Tasigna NDA #022068 Nilotinib Hydrochloride Capsule; Oral SUPPL-41 Novartis Labeling Approved Acetaminophen and Codeine Phosphate ANDA #040119 Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-21 Akorn Labeling Approved Acetaminophen and Codeine Phosphate ANDA #040119 Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-21 Akorn Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5192 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5192 Genzyme Labeling Approved Soliris BLA #125166 Eculizumab Injectable; Iv (Infusion) SUPPL-446 Alexion Pharm Labeling Approved Soliris BLA #125166 Eculizumab Injectable; Iv (Infusion) SUPPL-446 Alexion Pharm Labeling Approved Blincyto BLA #125557 Blinatumomab Injectable; Injection SUPPL-29 Amgen Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-2 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-2 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-16 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-19 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-23 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-2 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-3 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-4 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-8 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-9 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-11 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-16 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-19 Alembic Labeling Approved Duloxetine Hydrochloride ANDA #202949 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-23 Alembic Labeling Approved Lokelma NDA #207078 Sodium Zirconium Cyclosilicate For Suspension; Oral SUPPL-10 Astrazeneca Labeling Approved Imatinib Mesylate ANDA #207818 Imatinib Mesylate Tablet; Oral SUPPL-1 Natco Pharma Ltd Labeling Approved Imatinib Mesylate ANDA #207818 Imatinib Mesylate Tablet; Oral SUPPL-3 Natco Pharma Ltd Labeling Approved Tracleer NDA #209279 Bosentan Tablet, For Suspension; Oral SUPPL-10 Actelion Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Cipla Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-2 Cipla Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-4 Cipla Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-5 Cipla Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-7 Cipla Labeling Approved Dimethyl Fumarate ANDA #210305 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-8 Cipla Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-2 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-3 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-4 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-5 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210309 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-3 Glenmark Pharms Ltd Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-6 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-8 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-11 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-12 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-6 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-8 Twi Pharms Labeling Approved Dimethyl Fumarate ANDA #210382 Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-12 Twi Pharms Labeling Approved Vivimusta NDA #212209 Bendamustine Hydrochloride Solution; Intravenous SUPPL-4 Slayback Pharma Llc Labeling Approved Vivimusta NDA #212209 Bendamustine Hydrochloride Solution; Intravenous SUPPL-4 Slayback Pharma Llc Labeling Approved Estradiol ANDA #212313 Estradiol Cream; Vaginal SUPPL-1 Prasco Labeling Approved Estradiol ANDA #212313 Estradiol Cream; Vaginal SUPPL-1 Prasco Labeling Approved Regadenoson ANDA #213236 Regadenoson Solution; Intravenous SUPPL-4 Accord Hlthcare Manufacturing (CMC) Approved Regadenoson ANDA #213236 Regadenoson Solution; Intravenous SUPPL-4 Accord Hlthcare Manufacturing (CMC) Approved Dexmethylphenidate Hydrochloride ANDA #213813 Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-13 Granules Labeling Approved Butalbital, Acetaminophen and Caffeine ANDA #214288 Acetaminophen; Butalbital; Caffeine Capsule; Oral ORIG-1 Quagen   Approved Empaveli NDA #215014 Pegcetacoplan Solution; Subcutaneous SUPPL-6 Apellis Pharms Labeling Approved Empaveli NDA #215014 Pegcetacoplan Solution; Subcutaneous SUPPL-6 Apellis Pharms Labeling Approved Esomeprazole Sodium ANDA #215732 Esomeprazole Sodium Injectable; Intravenous SUPPL-2 Hainan Poly Labeling Approved Dichlorphenamide ANDA #215924 Dichlorphenamide Tablet; Oral SUPPL-1 Torrent Labeling Approved Dichlorphenamide ANDA #215924 Dichlorphenamide Tablet; Oral SUPPL-1 Torrent Labeling Approved Ultomiris BLA #761108 Ravulizumab-Cwvz Injectable; Injection SUPPL-35 Alexion Pharm Labeling Approved Ultomiris BLA #761108 Ravulizumab-Cwvz Injectable; Injection SUPPL-35 Alexion Pharm Labeling Approved Enjaymo BLA #761164 Sutimlimab-Jome Injectable; Injection SUPPL-4 Bioverativ Therapeutics Inc Labeling Approved feedtwitterfacebookyoutubeflickr Manage Subscriptions  |   |  Help ---------------------------------------------------------------------------------------------------------------------------------- This email was sent to [email protected] 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 GovDelivery logo
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