---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 8, 2014 at 6:18 AM
Subject: CDER New August 8, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Aug 8, 2014 at 6:18 AM
Subject: CDER New August 8, 2014
To: iammejtm@gmail.com
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 |
| This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
Jeremy Tobias Matthews
No comments:
Post a Comment