What's New on the FDA Drugs Site
March 26, 2014
- Acetaminophen Information (updated)
- Drugs@FDA Data Files (updated)
New and Generic Drug Approvals
March 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acephen | acetaminophen | Suppository;Rectal | G and W Labs | Labeling Revision |
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Emtriva | emtricitabine | Capsule;Oral | Gilead | Manufacturing Change or Addition |
| Estrogel | estradiol | Gel, Metered;Transdermal | Ascend | Labeling Revision |
| Estrogel | estradiol | Gel;Topical | Ascend | Labeling Revision |
| Femhrt | ethinyl estradiol; norethindrone acetate | Tablet;Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Firmagon | degarelix acetate | Powder;Subcutaneous | Ferring | Manufacturing Change or Addition |
| Fludarabine Phosphate | fludarabine phosphate | Injectable;Injection | Sandoz | Manufacturing Change or Addition |
| Incivek | telaprevir | Tablet;Oral | Vertex Pharms | Manufacturing Change or Addition |
| Metro I.V. In Plastic Container | metronidazole | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Synarel | nafarelin acetate | Spray, Metered;Nasal | Gd Searle Llc | Manufacturing Change or Addition |
| Twinject 0.15 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Twinject 0.3 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Versacloz | clozapine | Suspension;Oral | Jazz Pharms Iii | Manufacturing Change or Addition |
| Viagra | sildenafil citrate | Tablet;Oral | Pfizer Ireland | Manufacturing Change or Addition |
| Zenpep | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
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