December 12, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Nucala (mepolizumab), the first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lithium Carbonate Capsules (New - Discontinuation)
- Montelukast Sodium Chewable Tablet (New - Discontinuation)
- Sertraline Hydrochloride Tablets (New - Discontinuation)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Gluten in Drug Products and Associated Labeling Recommendations Draft Guidance for Industry (PDF - 136KB)
- Medications and Gluten
- National Drug Code Directory (updated)
- Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (PDF - 109KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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