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Updated Monday through Friday
- CDER Launches New Accelerating Rare disease Cures (ARC) Program
- 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
August 18, 2022
- Competitive Generic Therapy Approvals (updated)
- Drug Alert: FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection
August 17, 2022
- FDA Drug Shortages
- Indomethacin Injection (New - Discontinuation)
August 16, 2022
- Drugs@FDA Data Files (updated)
August 12, 2022
- FDA Drug Shortages
- Amino Acids (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)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Iodixanol Injection (Updated - Currently in Shortage)
- Iohexol Injection (Updated - Currently in Shortage)
- Isoniazid Injection (Updated - Currently in Shortage)
- Ketamine 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)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Rifampin Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride 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)
- Sterile Water for Injection (Updated - Currently in Shortage)
August 11, 2022
- FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer
- Virtual Workshop: Advancing Pre-Market Safety Analytics
- FDA approves capmatinib for metastatic non-small cell lung cancer
- FDA Drug Shortages
- Adenosine Injection (New - Discontinuation)
- Alprostadil Injection (New - Discontinuation)
- Amikacin Sulfate Injection (New - Discontinuation)
- Bleomycin Injection (New - Discontinuation)
- Dacarbazine Injection (New - Discontinuation)
- Daunorubicin Hydrochloride Injection (New - Discontinuation)
- Desmopressin Acetate Injection (New - Discontinuation)
- Epoprostenol Sodium for Injection and Sterile Diluent for Epoprostenol Sodium for Injection (New - Discontinuation)
- Etoposide (Toposar) Injection (New - Discontinuation)
- Haloperidol Decanoate Injection (New - Discontinuation)
- Idarubicin Hydrochloride Injection (New - Discontinuation)
- Ifosfamide Injection (New - Discontinuation)
- Leucovorin Calcium for Injection (New - Discontinuation)
- Medroxyprogesterone Acetate Injectable Suspension (New - Discontinuation)
- Methylprednisolone Acetate Injectable Suspension (New - Discontinuation)
- Mitoxantrone Injection (New - Discontinuation)
- Norepinephrine Bitartrate Injection (New - Discontinuation)
- Oceotide Acetate Injection (New - Discontinuation)
- Octreotide Acetate Injection (New - Discontinuation)
- Streptozocin (Zanosar) Sterile Powder (New - Discontinuation)
- Topotecan Injection (New - Discontinuation)
- Vecuronium Bromide Injection (New - Discontinuation)
- Vincristine Sulfate (Vincasar PFS) Injection (New - Discontinuation)
August 9, 2022
- Drugs@FDA Data Files (updated)
- CDER Statement: FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity
August 8, 2022
- FDA Drug Shortages
- Oxcarbazepine Oral Suspension (New - Discontinuation)
- Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution (New - Discontinuation)
August 5, 2022
- FDA Drug Shortages
- Leuprolide Acetate Injection (Currently in Shortage)
August 3, 2022
- FDA Drug Shortages
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Flurazepam Hydrochloride Capsules (New - Currently in Shortage)
- Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
August 2, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Daptomycin Injection (New - Discontinuation)
- Ertapenem Injection (New - Discontinuation)
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (updated)
- Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
August 1, 2022
- FDA Drug Shortages
- Erythromycin Ophthalmic Ointment (Updated - Currently in Shortage)
- Lutetium Lu 177 Dotatate (LUTATHERA) Injection (Updated - Resolved)
July 29, 2022
- Externally-led Patient-Focused Drug Development Meetings (Updated)
- Planning an EL-PFDD Meeting
- Upcoming EL-PFDD Meetings
- Final Guidance: Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry
- FDA Drug Safety Podcast: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
- FDA Drug Shortages
- Ampicillin for Injection (New - Discontinuation)
July 28, 2022
- Public Notification: Honeymoon Exclusive For Men & Women contains hidden drug ingredients
- Competitive Generic Therapy Approvals (updated)
July 26, 2022
- Drugs@FDA Data Files (updated)
- Guidance Snapshot Pilot (updated)
- Patent Certifications (updated)
July 22, 2022
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
- Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance (updated)
- FDA Drug Shortages
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Final Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (Updated)
- Final Guidance: Orange Book Questions and Answers (Updated)
- National Drug Code Directory
July 20, 2022
- Q&A with FDA | FDA - Conversation on Paxlovid (New podcast)
- CDER Conversation: CDER’s Drug Quality Sampling and Testing program
- Draft Guidance: Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
- Draft Guidance: Evaluation of Therapeutic Equivalence
- FDA Drug Shortages
- Adenosine Injection (New - Discontinuation)
- Alprostadil Injection (New - Discontinuation)
- Amikacin Sulfate Injection (New - Discontinuation)
- Bleomycin Injection (New - Discontinuation)
- Dacarbazine Injection (New - Discontinuation)
- Daunorubicin Hydrochloride Injection (New - Discontinuation)
- Desmopressin Acetate Injection (New - Discontinuation)
- Epoprostenol Sodium for Injection and Sterile Diluent for Epoprostenol Sodium for Injection (New - Discontinuation)
- Haloperidol Decanoate Injection (New - Discontinuation)
- Vecuronium Bromide for Injection (Updated - Discontinuation)
July 19, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Bumetanide Injection (New - Discontinuation)