What's New on the FDA Drugs Site
April 8, 2013
- Bioresearch Monitoring Information System (BMIS) Search
- Clinical Investigator Inspection List (CLIIL) Search
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: Bioequivalence Recommendations for Specific Products (updated)
- National Drug Code Directory (updated)
- Pediatric Statistics: Breakdown of FDAAA Completed Pediatric Studies (updated)
New and Generic Drug Approvals
April 5, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atorvastatin Calcium | atorvastatin calcium | Tablet; Oral | Kudco Ireland | Approval |
| Boniva | ibandronate sodium | Tablet; Oral | Hoffmann La Roche | Manufacturing Change or Addition |
| Coartem | artemether; lumefantrine | Tablet; Oral | Novartis | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable; Injection | Accord Hlthcare | Manufacturing Change or Addition |
| Gastromark | ferumoxsil | Suspension; Oral | Amag Pharms Inc | Manufacturing Change or Addition |
| Nexterone | amiodarone hydrochloride | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Nulojix | belatacept | Injectable; Injection | Bristol Myers Squibb | Labeling Revision |
| Nuvigil | armodafinil | Tablet; Oral | Cephalon | Manufacturing Change or Addition |
| Ofirmev | acetaminophen | Solution; Iv (Infusion) | Cadence Pharms | Manufacturing Change or Addition |
| Ovidrel | choriogonadotropin alfa | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Ovidrel | choriogonadotropin alfa | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Prolensa | bromfenac | Solution; Ophthalmic | Bausch and Lomb | Approval |
| Saizen | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Stalevo 100 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Stalevo 125 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Stalevo 150 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Stalevo 200 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Stalevo 50 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Stalevo 75 | carbidopa; entacapone; levodopa | Tablet; Oral | Orion Pharma | Manufacturing Change or Addition |
| Synalar | fluocinolone acetonide | Cream; Topical | Medimetriks Pharms | Manufacturing Change or Addition |
| Temozolomide | temozolomide | Aerosol; Oral | Sun Pharma Global | Tentative Approval |
| Xenical | orlistat | Capsule; Oral | Hoffmann La Roche | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable; Iv (Infusion) | Hospira Inc | Approval |
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