From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 05:51:18 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: June 4, 2008 |
The following new items were added to the CDRH web pages on June 2, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments. |  |  |
| Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments. | | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 09:18:30 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 18:59:21 -0500 (CDT)
Subject: CDER New 6/3 - 4/2008
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June 4, 2008
- Drugs@FDA Downloadable Data Files (updated)
- FDA issues an Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia).
- New and Generic Drug Approvals
- Furadantin (nitrofurantoin) Oral Suspension, Sciele Pharma, Inc., Labeling Revision
- Hydrochlorothiazide Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
- Omeprazole Delayed-Release Capsules, Andrx Pharmaceuticals, LLC, Approval
- ORTHO-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision
- ORTHO TRI-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision
- Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- VFEND (voriconazole) Tablets, Pfizer, Inc., Labeling Revision
- VFEND (voriconazole) Injection, Pfizer, Inc., Labeling Revision
- VFEND (voriconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
- Welchol (colesevelam hydrochloride) Tablets, Daiichi Sankyo, Inc., Manufacturing Change or Addition
June 3, 2008
- Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
- Ombudsman’s Annual Report for 2007
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 19:01:46 -0500 (CDT)
Subject: CDER New 6/2/2008
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June 2, 2008
- Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
- Guidance for Industry: Indexing Structured Product Labeling [PDF]
- New and Generic Drug Approvals
- Accolate (zafirlukast) Tablet, AstraZeneca Pharmaceuticals LP, Labeling Revision
- Acetaminophen and Codeine Phosphate Tablets, Interpharm, Inc., Approval
- Alprazolam Extended-Release Tablets, Interpharm, Inc., Approval
- Amantadine Hydrochloride Capsules, Banner Pharmacaps, Inc., Approval
- Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer Global Pharmaceuticals, Inc., Labeling Revision
- Cefpodoxime Proxetil Tablets, Sandoz, Inc., Approval
- Cetirizine Hydrochloride Syrup, Teva Pharmaceuticals USA
- Clobetasol Propionate Lotion, Actavis Mid Atlantic, LLC, Tentative Approval
- Ethosuximide Capsules, Covenant Pharma, Inc., Approval
- Hydroxyzine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
- Lotensin (benazepril hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Midazolam Hydrochloride Injection, Wockhardt USA, Inc., Approval
- Mometasone Furoate Cream, Glenmark Generics, Inc., USA, Approval
- Mometasone Furoate Ointment, Glenmark Generics, Inc., USA, Approval
- Mirena (levonorgestrel) Intrauterine Device, Bayer Healthcare Pharmaceuticals, Inc., Labeling Revision
- Ropinirole Hydrochloride Tablets, Wockhardt USA, Inc., Approval
- Temazepam Capsules, Mutual Pharmaceutical Company, Inc., Tentative Approval
- Topiramate Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 14:54:25 -0500 (CDT)
Subject: FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults
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FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF) Blockers regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF
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