What's New on the FDA Drugs Site
April 17, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information
- FDA Public Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer, May 5, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information
- Guidance for Industry:Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (PDF - 212KB)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 16, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Allegra Allergy | fexofenadine hydrochloride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Allegra Hives | fexofenadine hydrochloride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Baraclude | entecavir | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Claritin | loratadine | Syrup; Oral | Schering Plough | Manufacturing Change or Addition |
| Claritin Hives Relief | loratadine | Syrup; Oral | Schering Plough | Manufacturing Change or Addition |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release; Oral | Purdue Pharma Lp | Labeling Revision |
| Pioglitazone Hydrochloride and Metformin Hydrochloride | metformin hydrochloride; pioglitazone hydrochloride | Tablet; Oral | Sandoz | Approval |
| Qsymia | phentermine hydrochloride; topiramate | Capsule, Extended Release; Oral | Vivus | Labeling Revision |
| Valtropin | somatropin recombinant | Injectable; Injection | Lg Life | Manufacturing Change or Addition |
| Victoza | liraglutide recombinant | Solution; Subcutaneous | Novo Nordisk Inc | Labeling Revision |
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