---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 9, 2014 at 8:00 AM
Subject: CDER New July 9, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 9, 2014 at 8:00 AM
Subject: CDER New July 9, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 8, 2014
- Public Notification: Trim-Fast Slimming Softgel Contains Hidden Drug Ingredient
- Public Notification: Sliming (sic) Diet By Pretty White Contains Hidden Drug Ingredient
- Public Notification: Lipo 8 Burn Slim Capsules Contain Hidden Drug Ingredient
- Public Notification: 24 Ince Contains Hidden Drug Ingredient
- Public Notification: Lingzhi Cleansed Slim Tea Contains Hidden Drug Ingredient
- Public Notification: Mix Fruit Slimming Contains Hidden Drug Ingredients
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Cefazolin Injection (Currently in Shortage)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
July 7, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Desvenlafaxine | desvenlafaxine | Tablet, Extended Release;Oral | Alembic Pharms Ltd | Labeling Revision |
| Effexor Xr | venlafaxine hydrochloride | Capsule, Extended Release;Oral | Wyeth Pharms Inc | Labeling Revision |
| Indium In-111 Oxyquinoline | indium in-111 oxyquinoline | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Kerydin | tavaborole | Solution;Topical | Anacor Pharms Inc | Approval |
| Marqibo Kit | vincristine sulfate | Injectable, Liposomal;Intravenous | Talon Therap | Manufacturing Change or Addition |
| Telmisartan | telmisartan | Tablet; Oral | Glenmark Generics | Approval |
| Telmisartan | telmisartan | Tablet; Oral | Alembic Ltd | Approval |
| Telmisartan | telmisartan | Tablet;Oral | Mylan Pharms Inc | Approval |
| Telmisartan | telmisartan | Tablet;Oral | Torrent Pharms | Approval |
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Jeremy Tobias Matthews
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