What's New on the FDA Drugs Site
February 5, 2014
- ANDA Suitability Petition Reports (updated)
- Current Drug Shortages Index (updated)
- Resolved Drug Shortages: Aminocaproic Acid Injection
- Resolved Drug Shortages: Aminophylline Injection
- Resolved Drug Shortages: Atracurium Besylate Injection
- Resolved Drug Shortages: Furosemide Injection
- Resolved Drug Shortages: Hydromorphone Hydrochloride (Dilaudid) Injection
- Resolved Drug Shortages: Metoclopramide (Reglan) Injection
- Resolved Drug Shortages: Morphine Sulfate Injection
- Resolved Drug Shortages: Tromethamine (Tham) Injection
- Draft Guidance: Analgesic Indications: Developing Drug and Biological Products (PDF - 818KB)
- Draft Guidance: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF - 176KB)
- Draft Guidance: Providing Submissions in Electronic Format -- Standardized Study Data (PDF - 231KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Shortages Report to Congress
- Drugs@FDA Data Files (updated)
- FDA Drug Safety Podcast: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
- First-Time Generic Drug Approvals 2013 (updated)
- First-Time Generic Drug Approvals 2014 (updated)
- National Drug Code Directory
- Meeting Presentation: Use of Targeting in Drug Development (PDF - 1MB)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
February 4, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Doxercalciferol | doxercalciferol | Injectable; Injection | Sandoz Inc | Approval |
| Extraneal | icodextrin | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Lamivudine; Zidovudine | lamivudine; zidovudine | Tablet; Oral Suspension | Mylan Labs | Tentative Approval |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Manufacturing Change or Addition |
| Sandostatin | octreotide acetate | Injectable;Injection | Novartis | Manufacturing Change or Addition |
| Simponi Aria | golimumab | Injectable; Injection | Janssen Biotech | Labeling Revision |
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