From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 13 Jun 2008 08:28:21 -0500 (CDT)
Subject: CDER New 6/11 & 12/2008
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June 12, 2008
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Drugs@FDA Downloadable Data Files (updated)
- FDA releases its third issue of the FDA Drug Safety Newsletter.
- New and Generic Drug Approvals
- Almotriptan Malate Tablets, Teva Pharmaceuticals USA, Tentative Approval
- Amoxil (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
- Amoxil (amoxicillin) Tablets, GlaxoSmithKline, Labeling Revision
- Amoxil (amoxicillin) Oral Suspension, GlaxoSmithKline, Labeling Revision
- Amoxil (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
- AUGMENTIN 250 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
- AUGMENTIN 500 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
- AUGMENTIN 875 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
- Ciclopirox Gel, Nycomed US, Inc., Approval
- Levo-T (levothyroxine sodium) Tablets, Alara Pharmaceutical Corp., Labeling Revision
- Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates, Inc., Approval
- Ramipril Capsules, Lupin Pharmaceuticals, Inc., Approval
- Valsartan Tablets, IVAX Pharmaceuticals, Inc., Tentative Approval
- Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality
June 11, 2008
- ETHEX Corporation voluntarily recalls a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. MedWatch Safety Information
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format –Postmarketing Individual Case Safety Reports [PDF]
- Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/#Postmarketing
- Guidance for Industry: Revision: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications [PDF].
- To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http://www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://www.fda.gov/cder/regulatory/ersr/ectd.htm.
- Paragraph IV Patent Certifications (updated)
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 13 Jun 2008 12:43:13 -0500 (CDT)
Subject: Mammography What's New Update
You are subscribed to Mammography What's New for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
On May 27, 2008, FDA approved the State of Texas (STX) as a Mammography Quality Standards Act (MQSA) Certifying Agency.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 13 Jun 2008 19:04:28 -0500 (CDT)
Subject: ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
Fri, 13 Jun 2008 18:30:00 -0500
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.
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