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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
September 2, 2022
- FDA approves durvalumab for locally advanced or metastatic biliary tract cancer.
- FDA Drug Shortages
- Iodixanol Injection (Updated - Currently in Shortage)
- Iohexol Injection (Updated - Currently in Shortage)
September 1, 2022
August 31, 2022
- SBIA Conference: FDA NanoDay Symposium 2022
- Competitive Generic Therapy Approvals (updated)
- FDA Drug Shortages
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
August 30, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Fenoldopam Mesylate (Corlopam) Injection (New - Discontinuation)
- Procainamide Hydrochloride Injection (New - Discontinuation)
- Remifentanil Injection (Updated - Currently in Shortage)
- Synercid Injection (New -Discontinuation)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
August 26, 2022
- FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement
- Guidance E11A Pediatric Extrapolation (Draft)
- Guidance M12 Drug Interaction Studies (Draft)
- Guidance Q14 Analytical Procedure Development (Draft)
- Guidance Q2(R2) Validation of Analytical Procedures (Draft)
- Guidance E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (Final)
- FDA Drug Shortages
- Amphetamine Oral Suspension, Extended Release (Updated - Resolved)
- Bumetanide Injection (Updated - Currently in Shortage)
- Cefazolin Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Famotidine Injection (Updated - Resolved)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lipid Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
August 25, 2022
- SBIA Webinar: Study Data Standards Update for CBER: Your Guide to a Successful Submission
- Report on the State of Pharmaceutical Quality: Fiscal Year 2021 (new)
- FDA Drug Shortages
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Virtual Conference: FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
August 24, 2022
- Patent Certifications and Suitability Petitions (updated)
- FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspension
- FDA Drug Shortages
- Diazepam Rectal Gel (Updated - Currently in Shortage)
- Indigotindisulfonate Sodium Injection (Updated - Currently in Shortage)
August 23, 2022
- SBIA Webinar: An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
- Workshop: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development
August 22, 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)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexmedetomidine 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)
- 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)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride 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)
- Lorazepam Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Metronidazole 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)
- Pentostatin Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Remifentanil 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)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
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)