What's New on the FDA Drugs Site
September 19, 2014
- FDA approves Trulicity (dulaglutide) to treat type 2 diabetes in adults
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
September 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aloxi | palonosetron hydrochloride | Injectable;Intravenous | Helsinn Hlthcare | Labeling Revision |
| Aloxi | palonosetron hydrochloride | Capsule;Oral | Helsinn Hlthcare | Labeling Revision |
| Anzemet | dolasetron mesylate | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Anzemet | dolasetron mesylate | Injectable;Injection | Sanofi Aventis Us | Labeling Revision |
| Biltricide | praziquantel | Tablet;Oral | Bayer Hlthcare | Manufacturing Change or Addition |
| Cefazolin and Dextrose | cefazolin sodium | Injectable;Injection | B Braun | Efficacy Supplement with Clinical Data to Support |
| Cleocin Phosphate In Dextrose 5% In Plastic Container | clindamycin phosphate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Halcion | triazolam | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
| Hydralazine Hydrochloride | hydralazine hydrochloride | Tablet;Oral | Cadila Pharms Ltd | Approval |
| Megace Es | megestrol acetate | Suspension;Oral | Par Pharm | Labeling Revision |
| Ofloxacin | ofloxacin | Tablet;Oral | Cadila Pharms Ltd | Approval |
| Sancuso | granisetron | Film, Extended Release;Transdermal | Prostrakan Inc | Labeling Revision |
| Trulicity | dulaglutide | Injectable;Injection | Eli Lilly and Co | Approval |
| Vasostrict | vasopressin | Solution;Iv (Infusion) | Par Sterile Products | Manufacturing Change or Addition |
| Zofran | ondansetron hydrochloride | Injectable;Injection | Glaxosmithkline | Labeling Revision |
| Zofran | ondansetron hydrochloride | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Zofran | ondansetron hydrochloride | Solution;Oral | Glaxosmithkline | Labeling Revision |
| Zofran Odt | ondansetron | Tablet, Orally Disintegrating;Oral | Glaxosmithkline | Labeling Revision |
| Zofran Preservative Free | ondansetron hydrochloride | Injectable;Injection | Glaxosmithkline | Labeling Revision |
| Zuplenz | ondansetron | Film;Oral | Galena Biopharma Inc | Labeling Revision |
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