---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jul 15, 2014 at 5:25 AM
Subject: CDER New July 15, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jul 15, 2014 at 5:25 AM
Subject: CDER New July 15, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 14, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Cyanocobalamin (Vitamin B12) Injection (Currently in Shortage)
- Disopyramide Phosphate (Norpace) CR (New - Currently in Shortage)
- Methylprednisolone Sodium Succinate Injection (Currently in Shortage)
- Papaverine Hydrochloride Injection (Currently in Shortage)
- Technetium tc99m Exametazime Injection (Ceretec Kit) (New - Currently in Shortage)
- Trace Elements (Currently in Shortage)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
July 11, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atripla | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead | Manufacturing Change or Addition |
| Bravelle | urofollitropin | Injectable;Intramuscular, Subcutaneous | Ferring | Manufacturing Change or Addition |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Kadcyla | ado-trastuzumab emtansine | Vial; Single-Use | Genentech | Labeling Revision |
| Menopur | menotropins (fsh;lh) | Injectable;Subcutaneous | Ferring | Manufacturing Change or Addition |
| Rythmol | propafenone hydrochloride | Tablet;Oral | Glaxosmithkline Llc | Manufacturing Change or Addition |
| Rythmol Sr | propafenone hydrochloride | Capsule, Extended Release;Oral | Glaxosmithkline Llc | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable;Intramuscular | Watson Labs | Labeling Revision |
| Trelstar | triptorelin pamoate | Injectable;Intramuscular | Watson Labs | Labeling Revision |
| Trelstar | triptorelin pamoate | Injectable;Intramuscular | Watson Labs | Labeling Revision |
| Truvada | emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Injectable;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Powder;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
| Wellbutrin Xl | bupropion hydrochloride | Tablet, Extended Release;Oral | Valeant Intl | Labeling Revision |
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Jeremy Tobias Matthews
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