Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 05:49:33 -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: April 16, 2008 |
The following new items were added to the CDRH web pages on April 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | PMA Final Decisions for March 2008 |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 08:29:40 -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.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 09:55:48 -0500 (CDT)
Subject: CDER New
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April 15, 2008
- New and Generic Drug Approvals
- Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Labeling Revision
- Cleocin Phosphate in Dextrose 5% in Plastic Container (clindamycin phosphate) I.V. Sterile Solution, Pfizer, Labeling Revision
- Evamist (estradiol) Transdermal Spray, KV Pharma, Labeling Revision
- Luvox (fluvoxamine maleate) Tablets, Jazz Pharma, Approval
- PULMICORT FLEXHALER (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
- Trelstar Depot (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
- Trelstar LA (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
- Unasyn (ampicillin sodium, sulbactam sodium) Injection, Pfizer, Labeling Revision
- Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision
- Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Control Supplement
- Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Labeling Revision
- Paragraph IV Patent Certifications (updated)
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 12:06:09 -0500 (CDT)
Subject: Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)
Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)
Thu, 17 Apr 2008 11:44:00 -0500
The recalled "S'morestick Kits" were in limited distribution to Garden Ridge retail stores located in TX, KY, MO, TN, OK, NC, FL, SC, GA, IL, OH, VA, AR, MI, and IN, and bear the "Use By" date of "2/14/09". The "S'morestick Kit" is packaged in a clear plastic tube containing individual clear plastic packages of marshmallows, graham crackers, and chocolate pieces. S'morestick Kits subject to this recall do NOT have a "contains milk" statement following the ingredient statement affixed to the clear plastic tube. There is no health risk for consumers who are not allergic to milk.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 12:24:55 -0500 (CDT)
Subject: CFSAN Constituent Update April 16, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
April 16, 2008
Listeria Monocytogenes Guidance Documents
FDA recently announced the availability for public comment of two draft guidance documents regarding Listeria monocytogenes (73 FR 7293; February 7, 2008). One document is entitled "Compliance Policy Guide Sec. 555.320 Listeria monocytogenes" (the draft CPG) (Docket No. FDA-2008-D-0058). The second document is entitled "Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods" (the draft Guidance for Industry) (originally Docket No. 2007D-0474; now Docket FDA-2008-D-0096). We also announced a public meeting, to be held on March 28, 2008, to discuss the draft CPG (73 FR 7298; February 7, 2008).
When we announced the availability of the draft guidance documents and of the public meeting, we requested comment on the two draft documents. Although you may comment on any FDA guidance document at any time (see 21 CFR 10.115(g)(5)), the Notice of Availability (NOA) for FDA’s draft Compliance Policy Guide on Listeria monocytogenes requested that written or electronic comments on the draft guidance be submitted by April 7, 2008 (the NOA date) (73 FR 7293; February 7, 2008). In that NOA, we advised that written comments should be submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and that electronic comments should be submitted to http://www.regulations.gov.
At the March 28, 2008, FDA public meeting, we noted that we do not expect to finalize the draft CPG until there has been a reasonable time for the public to access the transcript, and emphasized that comments on a FDA guidance document may be submitted at any time, including after the date identified in the corresponding NOA. Given the relationship between the draft CPG and the draft Guidance for Industry, we would expect to finalize the Guidance for Industry after the same period of access.
FDA subsequently learned that the time frame for submitting electronic comments ordinarily closes on the NOA date. After the NOA date, the customary process has been to submit comments in writing to the Division of Dockets Management at the address noted above.
On April 14, 2008, FDA implemented a new process to enable stakeholders to continue to submit electronic comments on guidance documents after the NOA date. To submit comments on the draft CPG at www.regulations.gov, go to Document FDA-2008-D-0058-0005 (Compliance Policy Guide Sec. 555.320 Listeria monocytogenes - Draft Guidance) and click on the icon "Send a Comment or Submission." To submit comments on the draft Guidance to Industry at www.regulations.gov, go to Document FDA-2008-D-0096-0002 (Guidance for Industry - Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods - Draft Guidance) and click on the icon "Send a Comment or Submission."
FDA apologizes for any inconvenience due to the closure of the electronic portal during April 8 – 13, 2008.
Please direct any questions about this Update to Mary.Losikoff@fda.hhs.gov or call 301-436-1412.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 13:51:02 -0500 (CDT)
Subject: Drug Information Update- Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration received reports of loss of antidepressant effect and new or worsening side effects in some patients who switched from the brand name drug, Wellbutrin XL, used to treat depression, to a generic version of the drug. The FDA reviewed the safety and effectiveness of a generic version, bupropion hydrochloride extended release 300 milligram tablets, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals. The agency evaluated adverse event reports and other data in order to provide the public with current drug safety information.
The FDA has completed its evaluation of Teva’s version of generic bupropion extended- release tablets, marketed as Budeprion XL 300 milligram. The FDA considers Teva’s generic drug to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL 300 milligram. The FDA’s conclusions can be found in a review of therapeutic equivalence that was released today.
Wellbutrin XL is owned by GlaxoSmithKline,
Budeprion XL is manufactured by Impax Laboratories,
For more information, please visit:
Review of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg
www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm
Consumer Education: Generic Drugs
www.fda.gov/cder/consumerinfo/generic_text.htm
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 14:08:00 -0500 (CDT)
Subject: Enforcement Report for April 16, 2008
Enforcement Report for April 16, 2008
Wed, 16 Apr 2008 07:00:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 14:22:26 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
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