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Updated Monday through Friday
March 5, 2021
- Public Notifications
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Isoniazid Injection USP (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Tacrolimus Capsules (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
March 4, 2021
March 3, 2021
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Carbidopa, Levodopa and Entacapone, Tablets (New - Discontinuation)
- Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
March 2, 2021
- Drug Info Rounds Video - Medication Guides: Distribution Requirements for Health Care Professionals (March 2020)
- Phonetic and Orthographic Computer Analysis (POCA) Program (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
March 1, 2021
- FDA Drug Shortages
- Leuprolide Acetate Injection (Updated - Currently in Shortage)
February 26, 2021
- FDA Drug Shortages
- Succimer (Chemet) Capsules (New - Currently in Shortage)
- Public Notification: Vy & Tea contains hidden drug ingredient
February 25, 2021
- FDA Drug Shortages
- Azacitidine for Injection (Updated - Currently in Shortage)
- Belatacept (Nulojix) Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)
February 24, 2021
- Public Notification: Alpha Male Plus contains hidden drug ingredient
- FDA Drug Shortages
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
February 23, 2021
- Drugs@FDA Data Files (updated)
- Manual of Policies and Procedures (MAPP) 4301.1 Rev 3 Center for Drug Evaluation and Research Medical Policy Council
- FDA Drug Shortages
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
February 22, 2021
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Expanded Access INDs and Protocols (updated)
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency
- FDA Drug Shortages
- Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
February 19, 2021
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
February 18, 2021
- FDA Drug Shortages
- Bumetanide Tablets (New - Discontinuation)
- Cisatracurium Besylate Injection (Updated - Currently in Shortage)
- Diclofenac Sodium Topical Solution (New - Discontinuation)
February 17, 2021
- FY 2021 Generic Drug Science and Research Initiatives Public Workshop
- Drug Trials Snapshot: CABENUVA
- FDA Drug Shortages
- Hydroxyzine Pamoate Oral Capsules (Updated - Resolved)
February 16, 2021
- CDER Statement: FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia
- CDER Warning Letters (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- (Updated)
- Azacitidine for Injection (Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection, USP (Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (Currently in Shortage)
- Cefotetan Disodium Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Famotidine Injection (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Furosemide Injection, USP (Currently in Shortage)
- Hydralazine Hydrochloride Injection, USP (Currently in Shortage)
- Hydromorphone Hydrochloride Injection, USP (Currently in Shortage)
- Ketorolac Tromethamine Injection (Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage)
- Morphine Sulfate Injection (Currently in Shortage)
- Ondansetron Hydrochloride Injection (Currently in Shortage)
- Oxytocin Injection, USP Synthetic (Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Currently in Shortage)
- Sodium Bicarbonate Injection, USP (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
- (Updated 2/12/2021)
- Atropine Sulfate Injection (Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (Currently in Shortage)
- Calcitriol Injection USP 1MCG /ML (Currently in Shortage)
- Capreomycin Injection, USP (Currently in Shortage)
- Cisatracurium Besylate Injection (Currently in Shortage)
- Cyclopentolate Ophthalmic Solution (Currently in Shortage)
- Diltiazem Hydrochloride Injection (Currently in Shortage)
- Dimercaprol (Bal in Oil) Injection USP (Currently in Shortage)
- Dobutamine Hydrochloride Injection (Currently in Shortage)
- Dopamine Hydrochloride Injection (Currently in Shortage)
- Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Currently in Shortage)
- Erythromycin Ophthalmic Ointment (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Currently in Shortage)
- Hydralazine Hydrochloride Injection, USP (Currently in Shortage)
- Hydrocortisone Tablets, USP (Currently in Shortage)
- Hydromorphone Hydrochloride Injection, USP (Currently in Shortage)
- Ketamine Injection (Currently in Shortage)
- Ketorolac Tromethamine Injection (Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage)
- Lorazepam Injection, USP (Currently in Shortage)
- Midazolam Injection, USP (Currently in Shortage)
- Misoprostol Tablets (Currently in Shortage)
- Nalbuphine Hydrochloride Injection (Currently in Shortage)
- Ondansetron Hydrochloride Injection (Currently in Shortage)
- Pantoprazole Sodium for Injection (Currently in Shortage)
- Propofol Injectable Emulsion (Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Sulfasalazine Tablets (Currently in Shortage)
February 12, 2021
- FDA Drug Shortages
New
- Histreline Acetate Implant (2/11/2021 Currently in Shortage)
Updated
- Anagrelide Hydrochloride Capsules (2/10/2021 Currently in Shortage)
- Azacitidine for Injection (2/10/2021 Currently in Shortage)
- Cefepime Injection (2/10/2021 Resolved)
- Cisatracurium Besylate Injection (2/11/2021 Currently in Shortage)
- Dextrose 50% Injection (2/9/2021 Resolved)
- Ketamine Injection (2/9/2021 Currently in Shortage)
- Leuprolide Acetate Injection (2/11/2021 Currently in Shortage)
- Pantoprazole Sodium for Injection (2/9/2021 Currently in Shortage)
- Propofol Injectable Emulsion (2/9/2021 Currently in Shortage)
- Orange Book
February 11, 2021
- Office of Pharmaceutical Quality 2020 Annual Report
- Office of Generic Drugs 2020 Annual Report
- 2020 Drug Safety Priorities Report
February 10, 2021
- Drug Trials Snapshot: LUPKYNIS
- CDER’s Work to Meet User Fee Goals During the Pandemic
- CDER Warning Letters 2021 (updated)
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español: Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib)
- Drug Shortages: Non-Compliance With Notification Requirement (updated)
- Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program (updated)
February 9, 2021
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Azacitidine for Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
February 8, 2021
- Drug Trials Snapshot: VERQUVO
- FDA Drug Shortages
- Amino Acids (Updated - Currently in Shortage)
- Ceftazidime and Avibactam (AVYCAZ®) for Injection, 2 grams/0.5 grams (Updated - Currently in Shortage)
February 5, 2021
- FDA Drug Shortages
- Acetazolamide Injection (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
- Azacitidine for Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Enalaprilat Injection, USP (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lorazepam Injection, USP (Updated - Currently in Shortage)
- Methyldopa Tablets (Updated - Currently in Shortage)
- Midazolam Injection, USP (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Promethazine (Phenergan) Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Valproate Sodium Injection, USP (Updated - Currently in Shortage)
- Zinc Acetate Capsules (Updated - Currently in Shortage)
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
- GDUFA Reauthorization Sessions (updated)