---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jun 11, 2014 at 7:20 AM
Subject: CDER New June 11, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jun 11, 2014 at 7:20 AM
Subject: CDER New June 11, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 10, 2014
- Public Notification: La Jiao Shou Shen Contains Hidden Drug Ingredient
- Drug Firm Annual Registration Status Download File (updated)
- FDA Statement: FDA issues final rule on postmarketing safety report in electronic format
- Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.3MB)
- National Drug Code Directory
- Manual of Policies and Procedures (MAPP) 4655.0 Reference Checks (PDF - 167KB)
- Meeting Presentation: FDA Response to Drug Shortages (PDF - 465KB)
- Pediatric Exclusivity Statistics (updated)
- Pediatric Medical, Statistical, and Clinical Pharmacology Reviews (updated)
New and Generic Drug Approvals
June 9, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Solution;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Tablet, Orally Disintegrating;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Injectable;Intramuscular | Otsuka | Labeling Revision |
| Camptosar | irinotecan hydrochloride | Injectable;Injection | Pfizer Inc | Manufacturing Change or Addition |
| Caverject | alprostadil | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Cerebyx | fosphenytoin sodium | Injectable;Injection | Parke Davis | Manufacturing Change or Addition |
| Corvert | ibutilide fumarate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Depacon | valproate sodium | Injectable;Injection | Abbvie | Labeling Revision |
| Depakene | valproic acid | Capsule;Oral | Abbvie | Labeling Revision |
| Depakene | valproic acid | Syrup;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Tablet, Delayed Release;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets;Oral | Abbvie | Labeling Revision |
| Depakote Er | divalproex sodium | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Depo-Medrol | methylprednisolone acetate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Depo-Provera | medroxyprogesterone acetate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Depo-Provera | medroxyprogesterone acetate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Duloxetine Hydrochloride | duloxetine hydrochloride | Capsule, Delayed Release;Oral | Alembic Pharms Ltd | Approval |
| Eraxis | anidulafungin | Injectable;Iv (Infusion) | Vicuron | Manufacturing Change or Addition |
| Exforge | amlodipine besylate; valsartan | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Exforge Hct | amlodipine besylate; hydrochlorothiazide; valsartan | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Fexofenadine Hydrochloride | fexofenadine hydrochloride | Suspension;Oral | Actavis Mid Atlantic | Tentative Approval |
| Geodon | ziprasidone mesylate | Injectable;Intramuscular | Pfizer | Manufacturing Change or Addition |
| Hemabate | carboprost tromethamine | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Prostin Vr Pediatric | alprostadil | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Solu-Cortef | hydrocortisone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Solu-Medrol | methylprednisolone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Sporanox | itraconazole | Capsule;Oral | Janssen Pharms | Labeling Revision |
| Sporanox | itraconazole | Solution;Oral | Janssen Pharms | Labeling Revision |
| Vfend | voriconazole | Injectable;Iv (Infusion) | Pfizer | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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