---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 20, 2014 at 7:44 AM
Subject: CDER New August 20, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 20, 2014 at 7:44 AM
Subject: CDER New August 20, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 19, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Haloperidol Lactate Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Rifampin for Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- Trimipramine Maleate (SURMONTIL) Capsules (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
August 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Basaglar | insulin glargine | Injectable;Injection | Eli Lilly and Co | Tentative Approval |
| Cefazolin Sodium | cefazolin sodium | Injectable;Injection | Acs Dobfar | Chemistry New Strength |
| Dexmedetomidine Hydrochloride | dexmedetomidine hydrochloride | Injectable; Injection | Mylan Institutional | Approval |
| Dexmedetomidine Hydrochloride | dexmedetomidine hydrochloride | Injectable;Injection | Par Sterile Products | Approval |
| Docetaxel | docetaxel | Injectable;Injection | Sandoz | Manufacturing Change or Addition |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | Injectable;Injection | Hospira Inc | Manufacturing Change or Addition |
| Neurontin | gabapentin | Capsule;Oral | Pfizer Pharms | Labeling Revision |
| Neurontin | gabapentin | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Neurontin | gabapentin | Solution;Oral | Parke Davis | Labeling Revision |
| Rifampin | rifampin | Injectable;Injection | Emcure Pharms Ltd | Approval |
| Tecfidera | dimethyl fumarate | Capsule, Delayed Release;Oral | Biogen Idec Inc | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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