---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Aug 28, 2014 at 7:10 AM
Subject: CDER New August 28. 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Aug 28, 2014 at 7:10 AM
Subject: CDER New August 28. 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 27, 2014
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Calcium Gluconate Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Cefotetan Disodium Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Dihydroergotamine Mesylate Injection (Currently in Shortage)
- Famotidine Injection (Currently in Shortage)
- Haloperidol Lactate Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Phosphate (Glycophos) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- Drugs@FDA Data Files (updated)
- Pediatric List of Determinations including Written Request (updated)
New and Generic Drug Approvals
August 26, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dostinex | cabergoline | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
| Entecavir | entecavir | Tablet;Oral | Teva Pharms Usa | Approval |
| Furosemide | furosemide | Injectable;Injection | Emcure Pharms Ltd | Approval |
| Memantine Hydrochloride | memantine hydrochloride | Tablet;Oral | Macleods Pharms Ltd | Tentative Approval |
| Nevirapine | nevirapine | Tablet, Extended Release;Oral | Mylan Labs Ltd | Tentative Approval |
| Primaxin | cilastatin sodium; imipenem | Injectable;Injection | Merck | Manufacturing Change or Addition |
| Promacta | eltrombopag olamine | Tablet;Oral | Glaxosmithkline | Efficacy Supplement with Clinical Data to Support |
| Telmisartan | telmisartan | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
| Telmisartan and Amlodipine | telmisartan;amlodipine | Tablet;Oral | Mylan Pharms Inc | Approval |
| Xalkori | crizotinib | Capsule;Oral | Pf Prism Cv | Manufacturing Change or Addition |
| 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