---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 12, 2014 at 6:10 AM
Subject: CDER New June 12, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 12, 2014 at 6:10 AM
Subject: CDER New June 12, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 11, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- Current Drug Shortages Index (updated)
- Guidance for Industry: ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 215KB)
- National Drug Code Directory
- Non-Compliance Letters under 505B(d)(1) (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
June 10, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cleocin Phosphate | clindamycin phosphate | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Ddavp | desmopressin acetate | Injectable;Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Eszopiclone | eszopiclone | Tablet; Oral | Orchid Hlthcare | Approval |
| Foscavir | foscarnet sodium | Injectable;Injection | Clinigen Hlthcare | Manufacturing Change or Addition |
| Gemzar | gemcitabine hydrochloride | Injectable;Injection | Lilly | Labeling Revision |
| Humulin N | insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Lamictal | lamotrigine | Tablet;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal Cd | lamotrigine | Tablet, Chewable;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal Odt | lamotrigine | Tablet, Orally Disintegrating;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal Xr | lamotrigine | Tablet, Extended Release;Oral | Glaxosmithkline Llc | Labeling Revision |
| Levemir | insulin detemir recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Flexpen | insulin detemir recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Flextouch | insulin detemir recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Innolet | insulin detemir recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Penfill | insulin detemir recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Risedronate Sodium | risedronate sodium | Tablet; Oral | Apotex Inc | Approval |
| Risedronate Sodium | risedronate sodium | Tablet;Oral | Sun Pharma Global | Approval |
| Risedronate Sodium | risedronate sodium | Tablet;Oral | Sun Pharma Global | Tentative Approval |
| Risedronate Sodium | risedronate sodium | Tablet; Oral | Mylan Pharms Inc | Approval |
| Trobicin | spectinomycin hydrochloride | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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