What's New on the FDA Drugs Site
March 4, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
March 1, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Femcon Fe | ethinyl estradiol; norethindrone | Tablet, Chewable; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Geodon | ziprasidone hydrochloride | Capsule; Oral | Pfizer | Labeling Revision |
| Geodon | ziprasidone mesylate | Injectable; Intramuscular | Pfizer | Labeling Revision |
| Geodon | ziprasidone hydrochloride | Suspension; Oral | Pfizer Inc | Labeling Revision |
| Lo Loestrin Fe | ethinyl estradiol | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Lo Loestrin Fe | ethinyl estradiol; norethindrone acetate | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Lo Loestrin Fe | ferrous fumarate | Tablet; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Losartan Potassium; Hydrochlorothiazide | losartan potassium; hydrochlorothiazide | Tablet; Oral | Ipca Laboratories Ltd | Approval |
| Mepron | atovaquone | Suspension; Oral | Glaxosmithkline Llc | Labeling Revision |
| Mirapex | pramipexole dihydrochloride | Tablet; Oral | Boehringer Ingelheim | Labeling Revision |
| Mirapex Er | pramipexole dihydrochloride | Tablet, Extended Release; Oral | Boehringer Ingelheim | Labeling Revision |
| Onfi | clobazam | Tablet; Oral | Lundbeck Llc | Manufacturing Change or Addition |
| Somavert | pegvisomant | Injectable; Subcutaneous | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Sporanox | itraconazole | Capsule; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Travoprost | travoprost | Solution/Drops; Ophthalmic | Par Pharm | Approval |
| Veregen | sinecatechins | Ointment; Topical | Medigene Ag | Manufacturing Change or Addition |
| Vfend | voriconazole | Tablet; Oral | Pfizer | Manufacturing Change or Addition |
| Xarelto | rivaroxaban | Tablet; Oral | Janssen Pharms | Efficacy Supplement with Clinical Data to Support |
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