Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 15:05:50 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
PDUFA - User Fee Billable Products Approved Under Section 351 of the PHS Act - Updated
Posted: 9/26/2008
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 15:07:30 -0500 (CDT)
Subject: CDER New 9/22 - 26/2008
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September 26, 2008
- Guidance for Industry: Individual Product Bioequivalence Recommendations 19 Newly added Bioequivalents.
- Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial)
- Drugs Shortages: Resolved Drugs Shortages: Zanosar (Streptozocin) 1gm/vial Injection
- FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information
- New and Generic Drug Approvals
- Betamethasone Dipropionate Topical Cream, Glenmark Generics, Approval
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
- Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Labeling Revision
- Nabumetone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Noroxin (norfloxacin) Tablets, Merck & Co. Inc., Labeling Revision
- Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision
- Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
- Office of Generic Drugs: List of Authorized Generic Drugs (updated)
- Warning and Untitled Letters
- Adderall XR Capsules (Warning Letter)
- Concerta (methylphenidate HCl)
- Diovan (valsartan) Tablets
- Focalin XR (dexmethylphenidate)
- Methylin (methylphenidate HCl)
- Strattera (atomoxetine HCl) (Warning Letter)
September 25, 2008
- FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers (updated)
- Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]
- International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
- New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Torrent Pharmaceuticals, Ltd., Approval
- Carboplatin I.V. Injection, Sun Pharmaceutical Industries, Ltd., Approval
- Nasacort AQ (triamcinolone acetonide) Nasal Spray, Sanofi-Aventis US, LLC, Patient Population Altered
- RETROVIR (zidovudine) Capsules, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Syrup, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Tablets, GlaxoSmithKline, New Dosage Regimen
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., New Dosage Regimen
- Technetium Tc 99m Sestamibi (technettium tc-99m sestamibi kit) Injection, Mallinckrodt Inc., Approval
- Ventavis (iloprost) Inhalation Solution, Actelion, Ltd., Labeling Revision
September 24, 2008
- A List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd.
- Dissolution Methods Database (updated)
- Drugs@FDA Downloadable Data Files (updated)
- Drugs Shortages: Drugs to be Discontinued: Cefotan (cefotan injection) - updated
- Drugs Shortages: Drugs to be Discontinued: Mitozytrex (Mitomycin for Injection) - updated
September 23, 2008
September 22, 2008
- FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers
- FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS). Questions and Answers
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:55 -0500 (CDT)
Subject: Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
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Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
Fri, 26 Sep 2008 14:40:00 -0500
See Web site for additional information
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 18:26:04 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- Nutrition: Your Prescription for Health
The FDA this Week: Andy's Take -- Nutrition: Your Prescription for Health
Fri, 26 Sep 2008 21:09:00 -0500
We as patients often assume that a prescription for health involves taking medicines. The drugs that FDA approves are essential for treating disease, but perhaps the most important prescription to prevent many diseases is the food we eat.
My Take is that our food not only needs to be safe to protect our health – but also nutritious, in order to promote our health.
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 10:20:59 -0500 (CDT)
Subject: FDA MedWatch - Epoetin alfa- Preliminary Safety Findings Show More Deaths In Patients Given Epoetin-alpha Versus Placebo
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FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.
FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About An Ongoing Safety Review regarding this issue.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 11:03:00 -0500 (CDT)
Subject: FDA Updates Health Information Advisory on Melamine Contamination
FDA Updates Health Information Advisory on Melamine Contamination
Fri, 26 Sep 2008 10:28:00 -0500
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 14:02:42 -0500 (CDT)
Subject: Vaccines Stand Ready for Flu Season
Vaccines Stand Ready for Flu Season
Fri, 26 Sep 2008 13:30:00 -0500
FDA has approved six vaccines for the 2008-2009 flu season.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:54 -0500 (CDT)
Subject: Updated: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.
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Updated: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.
Fri, 26 Sep 2008 14:20:00 -0500
As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Full Version.
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:54 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
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Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
Fri, 26 Sep 2008 08:45:00 -0500
See Web site for additional information
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 20:02:54 -0500 (CDT)
Subject: QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26)
QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26)
Fri, 26 Sep 2008 18:58:00 -0500
QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.
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