What's New on the FDA Drugs Site
March 13, 2013
- Current Drug Shortages Index (updated)
- Drugs@FDA Data Files (updated)
- Guidance for Industry: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (PDF - 56KB)
- National Drug Code Directory (updated)
- Orange Book (updated)
New and Generic Drug Approvals
March 12, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Androgel | testosterone | Gel, Metered; Transdermal | Abbvie | Labeling Revision |
| Androgel | testosterone | Gel; Transdermal | Abbvie | Labeling Revision |
| Azasite | azithromycin | Solution/Drops; Ophthalmic | Inspire | Manufacturing Change or Addition |
| Duraclon | clonidine hydrochloride | Injectable; Injection | Mylan Institutional | Manufacturing Change or Addition |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
| Quinapril Hydrochloride; Hydrochlorothiazide | quinapril hydrochloride; hydrochlorothiazide | Tablet; Oral | Apotex Corp | Approval |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Labeling Revision |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Labeling Revision |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Xalkori | crizotinib | Capsule; Oral | Pfizer | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable; Injection | Emcure Pharma | Approval |
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