What's New on the FDA Drugs Site
September 25, 2013
- Current Drug Shortages Index (updated)
- Drugs@FDA Data Files (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) 7620.6 (PDF - 653KB) Preparation of Topics and Nomination of Experts For Development and Harmonization of International Scientific and Technical Guidelines
- National Drug Code Directory
- FDA Drug Safety Communication: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)
- Public Workshops on Proactive Compliance, Process Validation and Contract Manufacturing Operation, October 7-10, 2013, Hyatt Regency New Brunswick, New Brunswick, NJ 08901. Meeting Information
- Spanish Drug Safety Communication: Parches analgésicos Duragesic (fentanilo) : FDA requiere cambio de color de parches analgésicos Duragesic (fentanilo) para mayor seguridad y enfatiza que la exposición accidental a parches usados puede causar la muerte
New and Generic Drug Approvals
September 24, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arzerra | ofatumumab | Injectable; Injection | Glaxo Grp Ltd | Labeling Revision |
| Heparin Sodium | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Heparin Sodium In Plastic Container | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Heparin Sodium Preservative Free | heparin sodium | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Percodan | aspirin; oxycodone hydrochloride | Tablet;Oral | Endo Pharms | Manufacturing Change or Addition |
| Percodan | aspirin; oxycodone hydrochloride; oxycodone terephthalate | Tablet;Oral | Endo Pharms | Manufacturing Change or Addition |
| Percodan-Demi | aspirin; oxycodone hydrochloride; oxycodone terephthalate | Tablet;Oral | Endo Pharms | Manufacturing Change or Addition |
| Qsymia | phentermine hydrochloride; topiramate | Capsule, Extended Release;Oral | Vivus | Manufacturing Change or Addition |
| Remodulin | treprostinil | Injectable;Iv (Infusion)-Sc | United Therap | Labeling Revision |
| Rituxan | rituximab | Vial | Genentech | Labeling Revision |
| Sirolimus | sirolimus | Tablet; Oral | Zydus Pharms Usa Inc | Tentative Approval |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hikma Maple | Approval |
| Xylocaine | lidocaine hydrochloride | Jelly;Topical | Oak Pharms | Manufacturing Change or Addition |
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