What's New on the FDA Drugs Site
May 2, 2013
- Drug Firm Annual Registration Status (updated)
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
- FAERS Quarterly Data Files Documentation (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
May 1, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arimidex | anastrozole | Tablet; Oral | Astrazeneca | Labeling Revision |
| Horizant | gabapentin enacarbil | Tablet, Extended Release; Oral | Glaxo Grp Ltd | Labeling Revision |
| Loestrin 24 Fe | ethinyl estradiol; norethindrone acetate | Tablet; Oral | Warner Chilcott | Manufacturing Change or Addition |
| Myfortic | mycophenolic acid | Tablet, Delayed Release; Oral | Novartis | Labeling Revision |
| Myfortic | mycophenolic acid | Tablet, Delayed Release; Oral | Novartis | Manufacturing Change or Addition |
| Neurontin | gabapentin | Capsule; Oral | Pfizer Pharms | Labeling Revision |
| Neurontin | gabapentin | Tablet; Oral | Pfizer Pharms | Labeling Revision |
| Neurontin | gabapentin | Solution; Oral | Parke Davis | Labeling Revision |
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