---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 19, 2014 at 10:41 AM
Subject: CDER New June 19, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jun 19, 2014 at 10:41 AM
Subject: CDER New June 19, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 18, 2014
- Drugs@FDA Data Files (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry:Uncomplicated Gonorrhea: Developing Drugs for Treatment (PDF - 290KB)
- List of Determinations Including Written Request (updated)
- Manual of Policies and Procedures (MAPP) 4643.4 CDER Office Space Requests (PDF - 455KB)
- MedWatch Safety Alert:Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
June 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advair Diskus 100/50 | fluticasone propionate; salmeterol xinafoate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Advair Diskus 250/50 | fluticasone propionate; salmeterol xinafoate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Advair Diskus 500/50 | fluticasone propionate; salmeterol xinafoate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Advair Hfa | fluticasone propionate; salmeterol xinafoate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Altabax | retapamulin | Ointment;Topical | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Beconase Aq | beclomethasone dipropionate monohydrate | Spray, Metered;Nasal | Glaxosmithkline | Manufacturing Change or Addition |
| Exalgo | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Mallinckrodt Inc | Labeling Revision |
| Flonase | fluticasone propionate | Spray, Metered;Nasal | Glaxosmithkline | Manufacturing Change or Addition |
| Flovent Diskus 100 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Flovent Diskus 250 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Flovent Diskus 50 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Flovent Hfa | fluticasone propionate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Reclast | zoledronic acid | Injectable;Iv (Infusion) | Novartis | Manufacturing Change or Addition |
| Technescan | technetium tc-99m oxidronate kit | Injectable;Injection | Mallinckrodt | Manufacturing Change or Addition |
| Ventolin Hfa | albuterol sulfate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Veramyst | fluticasone furoate | Spray, Metered;Nasal | Glaxosmithkline | Manufacturing Change or Addition |
| Zometa | zoledronic acid | Injectable;Iv (Infusion) | Novartis | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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