What's New on the FDA Drugs Site
October 6, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Electronic Common Technical Document (eCTD) Important Notices (updated)
- FDA Drug Shortages
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Ioxilan Injection (Oxilan) (New - Discontinuation)
- Phentolamine Mesylate Injection (Updated - Currently in Shortage)
- Paragraph IV Patent Certifications (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting
New and Generic Drug Approvals
October 5, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Gattex Kit | teduglutide recombinant | Powder;Subcutaneous | Nps Pharms Inc | Manufacturing Change or Addition |
| Glucotrol Xl | glipizide | Tablet, Extended Release;Oral | Pfizer | Labeling Revision |
| Ic-Green | indocyanine green | Injectable;Injection | Akorn | Labeling Revision |
| Olmesartan Medoxomil | olmesartan medoxomil | Tablet;Oral | Torrent Pharms Ltd | Tentative Approval |
| Olysio | simeprevir sodium | Capsule;Oral | Janssen Prods | Efficacy Supplement with Clinical Data to Support |
| Tobi | tobramycin | Solution;Inhalation | Novartis Pharms | Labeling Revision |
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Wednesday, October 7, 2015
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