CDER New: 6/1/2022

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 May 31, 2022 Drugs@FDA Data Files (updated) FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications FDA Drug Shortages Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Resolved) Atropine Sulfate Injection (Updated - Currently in Shortage) Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage) Bumetanide Injection (Updated - Currently in Shortage) Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Dextrose 25% Injection (Updated - Currently in Shortage) Dextrose 5% Injection (Updated - Currently in Shortage) Dextrose 50% Injection (Updated - Currently in Shortage) Diltiazem Hydrochloride Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Dopamine Hydrochloride Injection (Updated - Currently in Shortage) Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Furosemide Injection (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage) Lorazepam Injection (Updated - Currently in Shortage) Mannitol Injection (Updated - Currently in Shortage) Methylprednisolone Acetate Injection (Updated - Currently in Shortage) Midazolam Injection (Updated - Currently in Shortage) Morphine Sulfate Injection (Updated - Currently in Shortage) Pantoprazole Sodium for Injection (Updated - Currently in Shortage) Potassium Acetate Injection (Updated - Currently in Shortage) Potassium Chloride Concentrate Injection (Updated - Currently in Shortage) Rifampin Injection (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Sodium Acetate Injection (Updated - Currently in Shortage) Sodium Bicarbonate Injection (Updated - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage) Sodium Chloride 23.4% Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) Sodium Phosphates Injection (Updated - Currently in Shortage) Sterile Water for Injection (Updated - Currently in Shortage) Umbrasilib Tosylate Tablets (Updated - Discontinuation) Vecuronium Bromide for Injection (Updated - Currently in Shortage) 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 27, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Azithromycin ANDA #065212 Azithromycin Tablet; Oral SUPPL-35 Sandoz Labeling Approved Quinaretic ANDA #076374 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-11 Lupin Labeling Approved Quinaretic ANDA #076374 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-11 Lupin Labeling Approved Quinaretic ANDA #076374 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-12 Lupin Labeling Approved Quinaretic ANDA #076374 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-13 Lupin Labeling Approved Nitrofurantoin ANDA #091095 Nitrofurantoin, Macrocrystalline Capsule; Oral SUPPL-5 Actavis Labs Fl Inc Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #091524 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-9 Apotex Corp Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #091524 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-9 Apotex Corp Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #091524 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-11 Apotex Corp Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #091524 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-12 Apotex Corp Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #091524 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-13 Apotex Corp Labeling Approved Yervoy BLA #125377 Ipilimumab Injectable; Injection SUPPL-122 Bristol Myers Squibb Efficacy Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-105 Bristol Myers Squibb Efficacy Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-106 Bristol Myers Squibb Efficacy Approved Tafinlar NDA #202806 Dabrafenib Mesylate Capsule; Oral SUPPL-23 Novartis Efficacy Approved Aripiprazole ANDA #203906 Aripiprazole Solution; Oral SUPPL-9 Amneal Pharms Labeling Approved Aripiprazole ANDA #203906 Aripiprazole Solution; Oral SUPPL-9 Amneal Pharms Labeling Approved Mekinist NDA #204114 Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-23 Novartis Efficacy Approved Tadalafil ANDA #206285 Tadalafil Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved Amantadine Hydrochloride ANDA #212407 Amantadine Hydrochloride Tablet; Oral ORIG-1 Edenbridge Pharms   Approved Evrysdi NDA #213535 Risdiplam For Solution; Oral SUPPL-3 Genentech Inc Efficacy Approved Evrysdi NDA #213535 Risdiplam For Solution; Oral SUPPL-5 Genentech Inc Efficacy Approved Levetiracetam ANDA #215069 Levetiracetam Tablet; Oral ORIG-2 Sciegen Pharms Inc   Approved Ibuprofen ANDA #215311 Ibuprofen Suspension; Oral ORIG-1 Strides Pharma   Approved Minocycline Hydrochloride ANDA #215466 Minocycline Hydrochloride Tablet; Oral ORIG-1 Beximco Pharms Usa   Approved Levetiracetam ANDA #216375 Levetiracetam Tablet; Oral ORIG-1 Alkem Labs Ltd   Approved Beovu BLA #761125 Brolucizumab-Dbll Injectable; Intravitreal SUPPL-8 Novartis Pharms Corp Efficacy Approved 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 Atnaa NDA #021175 Atropine; Pralidoxime Chloride Injectable; Intramuscular SUPPL-47 Us Army Labeling Approved Atnaa NDA #021175 Atropine; Pralidoxime Chloride Injectable; Intramuscular SUPPL-47 Us Army Labeling Approved Aveed NDA #022219 Testosterone Undecanoate Injectable; Intramuscular SUPPL-19 Endo Pharms Inc REMS Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #077093 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-19 Mylan Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #077093 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-18 Mylan Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #077093 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-19 Mylan Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #077093 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #077093 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-21 Mylan Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #078450 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-21 Aurobindo Pharma Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #078450 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-17 Aurobindo Pharma Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #078450 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-21 Aurobindo Pharma Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #078450 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-24 Aurobindo Pharma Labeling Approved Quinapril Hydrochloride and Hydrochlorothiazide ANDA #078450 Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-26 Aurobindo Pharma Labeling Approved Atomoxetine Hydrochloride ANDA #090609 Atomoxetine Hydrochloride Capsule; Oral SUPPL-1 Dr Reddys Labeling Approved Atomoxetine Hydrochloride ANDA #090609 Atomoxetine Hydrochloride Capsule; Oral SUPPL-5 Dr Reddys Labeling Approved Atomoxetine Hydrochloride ANDA #090609 Atomoxetine Hydrochloride Capsule; Oral SUPPL-1 Dr Reddys Labeling Approved Atomoxetine Hydrochloride ANDA #090609 Atomoxetine Hydrochloride Capsule; Oral SUPPL-5 Dr Reddys Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5185 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5185 Genzyme Labeling Approved Nitisinone ANDA #212390 Nitisinone Capsule; Oral ORIG-1 Dipharma   Approved Rocuronium Bromide ANDA #212668 Rocuronium Bromide Injectable; Injection ORIG-1 Prinston Inc   Approved Paroxetine Hydrochloride ANDA #213612 Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Sinotherapeutics Inc Manufacturing (CMC) Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma Labeling Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma Labeling Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma 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 Arformoterol Tartrate ANDA #215385 Arformoterol Tartrate Solution; Inhalation ORIG-1 Sun Pharm   Approved Atropine Sulfate ANDA #216120 Atropine Sulfate Solution; Intravenous ORIG-1 Am Regent   Approved Bumetanide ANDA #216434 Bumetanide Injectable; Injection ORIG-1 Gland Pharma Ltd   Approved Fylnetra BLA #761084 Pegfilgrastim-Pbbk Injectable; Injection ORIG-1 Kashiv Biosciences Llc 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