---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 26, 2014 at 7:19 AM
Subject: CDER New June 26, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 26, 2014 at 7:19 AM
Subject: CDER New June 26, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 25, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
June 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cardizem | diltiazem hydrochloride | Tablet;Oral | Valeant Intl | Manufacturing Change or Addition |
| Chlorhexidine Gluconate | chlorhexidine gluconate | Cloth;Topical | Sage Prods | Labeling Revision |
| Elelyso | taliglucerase alfa | Powder;Iv (Infusion) | Pfizer | Manufacturing Change or Addition |
| Fusilev | levoleucovorin calcium | Powder;Iv (Infusion) | Spectrum Pharms | Manufacturing Change or Addition |
| Fusilev | levoleucovorin calcium | Solution;Iv (Infusion) | Spectrum Pharms | Manufacturing Change or Addition |
| Imiquimod | imiquimod | Cream;Topical | Strides Arcolab Ltd | Approval |
| Omega-3-Acid Ethyl Esters | omega-3-acid ethyl esters | Capsule;Oral | Par Pharm Inc | Approval |
| Paricalcitol | paricalcitol | Capsule; Oral | Dr Reddys Labs Ltd | Approval |
| Paricalcitol | paricalcitol | Capsule;Oral | Anchen Pharms | Approval |
| Ravicti | glycerol phenylbutyrate | Liquid;Oral | Hyperion Therap Inc | Labeling Revision |
| Solu-Cortef | hydrocortisone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Vfend | voriconazole | Injectable;Iv (Infusion) | Pfizer | Manufacturing Change or Addition |
| Zithromax | azithromycin | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Zosyn In Plastic Container | piperacillin sodium; tazobactam sodium | Injectable;Injection | Wyeth Pharms Inc | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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