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Updated Monday through Friday
March 11, 2022
- FDA approves olaparib for adjuvant treatment of high-risk early breast cancer
- Competitive Generic Therapy Approvals
- FDA Drug Shortages
- Misoprostol Tablets (Updated - Resolved)
- Orange Book
- SBIA Webinar: Generic Drugs Forum 2022: The Current State of Generic Drugs
March 10, 2022
- Drugs@FDA Data Files (updated)
March 9, 2022
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Paclitaxel Injection (protein-bound particles) (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
March 8, 2022
- Drugs@FDA Data Files (updated)
March 7, 2022
- CDER Spotlight: Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse
March 4, 2022
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (New - Currently in Shortage)
- Dextrose 5% Injection (New - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lipid Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Protamine Sulfate Injection (Updated - Currently in Shortage)
- Rifampin Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride 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 (Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Streptozocin Powder for Injection (New - Currently in Shortage)
- Public Notification: Wonderful Honey contains hidden drug ingredient
March 3, 2022
- FDA Drug Shortages
- Amino Acids (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
March 2, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Cysteamine Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
March 1, 2022
- FDA approves drug for adults with rare form of bone marrow disorder
- FDA Drug Shortages
- Dextrose 10% Injection (New - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Guidance for Industry
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
- Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
- Pre-Launch Activities Importation Requests (PLAIR)
February 28, 2022
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (New - Currently in Shortage)
- Imipramine Tablets (New - Discontinuation)
February 25, 2022
- FDA updates Sotrovimab emergency use authorization
- FDA Drug Shortages
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
February 24, 2022
- Competitive Generic Therapy Approvals (updated)
- CDER Statement: FDA authorizes revisions to Evusheld dosing
- FDA Drug Shortages
- Cefazolin Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
February 22, 2022
- Office of Pharmaceutical Quality
- Drugs@FDA Data Files (updated)
- OPDP’s Social Science Research Program: Aiming to Understand How Health Care Providers and Patients Interpret Prescription Drug Information
- Emerging Technology Program (Updated)
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Azithromycin (Azasite) Ophthalmic Solution 1% (New - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Technetium Tc 99m Sulfur Colloid Injection (Updated - Currently in Shortage)
February 18, 2022
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (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)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine 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)
- Metronidazole Injection (Updated - Currently in Shortage)
February 17, 2022
- FDA Drug Shortages
- Rifampin Capsules (Updated - Currently in Shortage)
- Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (updated)
February 16, 2022
- FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray
- FDA Drug Shortages
- Dextrose 5% Injection (New - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
February 15, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Bumetanide Injection (New - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Technetium Tc 99m Sulfur Colloid Injection (Updated - Currently in Shortage)
February 14, 2022
- FDA 正调查淋巴瘤药物Ukoniq (厄布利塞)可能增加的死亡风险 (Chinese language translation of Drug Safety Communication: FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
- FDA Drug Shortages
- Dextrose 5% Injection (New - Currently in Shortage)
- Office of Generic Drugs 2021 Annual Report
February 11, 2022
- Competitive Generic Therapy Approvals (updated)
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español: La FDA investiga un posible aumento del riesgo de muerte con el uso del medicamento Ukoniq (umbralisib) como tratamiento para el linfoma
- Orange Book