---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 13, 2014 at 5:46 AM
Subject: CDER New August 13, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Aug 13, 2014 at 5:46 AM
Subject: CDER New August 13, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
August 12, 2014
- Released REMS (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Atropine Sulfate Injection (Currently in Shortage)
- Bumetanide Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Sufentanil Citrate (Sufenta) Injection (Currently in Shortage)
- Meeting Presentation: Office of Pharmaceutical Quality: Global Drug Development and its Impact on CDER's Drug Review Process Symposium (PDF - 996KB)
- National Drug Code Directory
- Pediatric Exclusivity Granted (updated)
- Warning Letters 2014 (updated)
New and Generic Drug Approvals
August 11, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alimta | pemetrexed disodium | Injectable;Iv (Infusion) | Lilly | Manufacturing Change or Addition |
| Concerta | methylphenidate hydrochloride | Tablet, Extended Release;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Gemzar | gemcitabine hydrochloride | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Glucagon | glucagon recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff | follitropin alfa/beta | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Humatrope | somatropin recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Intron A | interferon alfa-2b | Vial | Schering | Labeling Revision |
| Namenda | memantine hydrochloride | Solution;Oral | Forest Labs | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Quinidine Gluconate | quinidine gluconate | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Saizen | somatropin recombinant | Injectable;Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable;Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Zorvolex | diclofenac | Capsule;Oral | Iroko Pharms Llc | Manufacturing Change or Addition |
| Zyprexa | olanzapine | Injectable;Intramuscular | Lilly | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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