What's New on the FDA Drugs Site
March 14, 2012
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Current Drug Shortages Index (updated)
- FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes
- FDA Drug Safety Podcast: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
New and Generic Drug Approvals
March 13, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alimta | pemetrexed disodium | Injectable; Iv (Infusion) | Lilly | Manufacturing Change or Addition |
| Amyvid | florbetapir f-18 | Solution; Intravenous | Avid Radiopharms Inc | Manufacturing Change or Addition |
| Androgel | testosterone | Gel, Metered; Transdermal | Abbvie | Manufacturing Change or Addition |
| Androgel | testosterone | Gel; Transdermal | Abbvie | Manufacturing Change or Addition |
| Avonex | interferon beta-1a | Vial | Biogen | Labeling Revision |
| Celestone Soluspan | betamethasone acetate; betamethasone sodium phosphate | Injectable; Injection | Schering | Manufacturing Change or Addition |
| Cetrotide | cetrorelix | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Claritin-D | loratadine; pseudoephedrine sulfate | Tablet, Extended Release; Oral | Schering Plough | Manufacturing Change or Addition |
| Desowen | desonide | Cream; Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Exelon | rivastigmine | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
| Fluvoxamine Maleate | fluvoxamine maleate | Capsule, Extended Release; Oral | Anchen Pharms | Approval |
| Forteo | teriparatide recombinant human | Injectable; Subcutaneous | Lilly | Manufacturing Change or Addition |
| Fuzeon | enfuvirtide | Injectable; Subcutaneous | Roche | Manufacturing Change or Addition |
| Jevtana Kit | cabazitaxel | Solution; Iv (Infusion) | Sanofi Aventis Us | Manufacturing Change or Addition |
| Latisse | bimatoprost | Solution/Drops; Topical | Allergan | Manufacturing Change or Addition |
| Lymphoseek | technetium tc 99m tilmanocept | Injectable; Injection | Navidea Biopharmaceuticals Inc | Approval |
| Norethindrone and Ethinyl Estradiol and Ferrous Fumarate | ethinyl estradiol; norethindrone | Tablet, Chewable; Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Precedex | dexmedetomidine hydrochloride | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Rayos | prednisone | Tablet, Delayed Release; Oral | Horizon Pharma | Manufacturing Change or Addition |
| Xalatan | latanoprost | Solution/Drops; Ophthalmic | Pharmacia and Upjohn | Manufacturing Change or Addition |
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