What's New on the FDA Drugs Site
August 7, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections
- FDA Drug Shortages: New and Updated
- Dihydroergotamine Mesylate Injection (Currently in Shortage)
- Epinephrine Injection (Currently in Shortage)
- Memantine Hydrochloride (Namenda) XR Capsules (Currently in Shortage)
- Pancuronium Bromide Injection (Currently in Shortage)
- Ranitidine Hydrochloride (Zantac) Injection (Currently in Shortage)
- Tiopronin (Thiola) (Currently in Shortage)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
August 6, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Fludeoxyglucose F18 | fludeoxyglucose | Injectable;Injection | Univ Iowa Hosps | Approval |
| Orbactiv | oritavancin diphosphate | Powder, For Injection Solution, Lyophilized Powder | Medicines Co | Approval |
| Phentermine Hydrochloride | phentermine hydrochloride | Tablet;Oral | Aurolife Pharma Llc | Approval |
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