From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 13 May 2008 12:39:27 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Medical Device Recall: BioArchive (Vapor Bypass Assembly), Thermogenesis Corporation
Posted: 5/13/2008; Recall Date: 5/7/2008
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 13 May 2008 14:05:37 -0500 (CDT)
Subject: FDA Safety Update: Asthma Medications
FDA Safety Update: Asthma Medications
Tue, 13 May 2008 12:56:00 -0500
May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 13 May 2008 14:09:02 -0500 (CDT)
Subject: Start at the Store: 7 Ways to Prevent Foodborne Illness
Start at the Store: 7 Ways to Prevent Foodborne Illness
Tue, 13 May 2008 12:56:00 -0500
Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 13 May 2008 16:52:16 -0500 (CDT)
Subject: CDER New 5/12/2008
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May 12, 2008
- Drug Shortage: Digitek (digoxin tablets, USP)
- FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information
- New and Generic Drug Approvals
- Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
- Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
- Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
- Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
- Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
- Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
- Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
- Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
- Acarbose Tablets, Roxane Laboratories, Inc., Approval
- Acarbose Tablets, Cobalt Laboratories, Approval
- Actos (pioglitazone hydrochloride), Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
- Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo Research, Labeling Revision
- Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension, Alcon, Labeling Revision
- Calcipotriene Topical Solution, Nycomed US, Inc., Approval
- Carboplatin Injection, EBEWE Pharma, Approval
- Inderal (propranolol hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Inspra (eplerenone) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
- Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- Mepron (atovaquone) Suspension, GlaxoSmithKline, Labeling Revision
- Nevanac (nepafenac) Ophthalmic Suspension, Alcon, Labeling Revision
- Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., New or Modified Indication
- Uroxatral (alfuzosin hydrochloride) Extended Release Tablets, Sanofi-Aventis US, LLC, Labeling Revision
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 13 May 2008 16:53:32 -0500 (CDT)
Subject: CDER New 5/13/2008
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May 13, 2008
- CDER Organization Charts [HTML] [PDF] (updated)
- Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary
- New and Generic Drug Approvals
- Ceftriaxone and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
- Children's Cetirizine Hydrochloride Allergy Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
- Children's Cetirizine Hydrochloride Hives Relief Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
- Desmopressin Acetate Tablets, Ferring Pharmaceuticals, Inc., Approval
- Drospirenone and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval
- Emtricitabine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval
- Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- OraVerse (phentolamine mesylate) Injection, Novalar Pharmaceuticals, Inc., Approval
- Primaxin I.M. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
- Primaxin I.V. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
- TACLONEX SCALP (calcipotriene and betamethasone dipropionate) Topical Suspension, Leo Pharmaceutical Products, Ltd., Approval
- Timentin (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
- Timentin in Plastic Container (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
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