April 9, 2014
- Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction. June 9, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503, Silver Spring, MD. Meeting Information
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
What's New on the FDA Drugs Site
Date
Paste links here
New and Generic Drug Approvals
April 8, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Augmentin Es-600 | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Isentress | raltegravir potassium | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Isentress | raltegravir potassium | Tablet, Chewable;Oral | Merck Sharp Dohme | Labeling Revision |
| Isentress | raltegravir potassium | Powder;Oral | Merck Sharp Dohme | Labeling Revision |
| Kalydeco | ivacaftor | Tablet;Oral | Vertex Pharms | Labeling Revision |
| Ortho-Cept | desogestrel; ethinyl estradiol | Tablet;Oral-21 | Janssen Pharms | Manufacturing Change or Addition |
| Ortho-Cept | desogestrel; ethinyl estradiol | Tablet;Oral-28 | Janssen Pharms | Manufacturing Change or Addition |
| Oxaliplatin | oxaliplatin | Injectable;Injection | Sun Pharma Global | Approval |
| Oxaliplatin | oxaliplatin | Injectable;Injection | Sun Pharma Global | Tentative Approval |
| Synthroid | levothyroxine sodium | Tablet;Oral | Abbvie | Manufacturing Change or Addition |
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