U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 09:03:47 -0500 (CDT)
Subject: FDA Revises Process for Responding to Drug Applications

FDA Revises Process for Responding to Drug Applications
Wed, 09 Jul 2008 08:40:00 -0500

The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 09:41:20 -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.

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Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 10:52:17 -0500 (CDT)
Subject: CDER New 7/7 & 8/2008

July 8, 2008

• FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs. Drug Information
• New and Generic Drug Approvals
  • Abraxane (paclitaxel) I.V. Suspension, Abraxis Bioscience, Inc., Labeling Revision
  • Alocril (nedocromil sodium) Ophthalmic Solution, Allergan, Inc., Labeling Revision
  • Flovent HFA (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
  • Forteo (teriparatide [rDNA origin]) Subcutaneous Injection, Eli Lilly and Co., Control Supplement
  • Optivar (azelastine hydrochloride) Ophthalmic Solution, Meda Pharmaceuticals, Inc., Package Change
  • Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval
  • Supprelin LA (histrelin acetate) Subcutaneous Implant, Indevus Pharmaceuticals, Inc., Package Change
  • TYKERB (lapatinib ditosylate) Tablets, GlaxoSmithKline, Labeling Revision

July 7, 2008

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated)
• Heparin Screening Methods (updated)

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Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 11:03:09 -0500 (CDT)
Subject: Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Wed, 09 Jul 2008 10:15:00 -0500

Baxter has discontinued Revex production.

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Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 15:49:59 -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.

A.) "Midwest Flooding - Guidance for Mammography Facilities."

B) "Governmental Entity (GE) Audit 2008 to Begin This Month."

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Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jul 2008 16:51:11 -0500 (CDT)
Subject: CDER New 7/9/2008

July 9, 2008

• Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
• Drugs@FDA Downloadable Data Files (updated)
• FDA revises its process for responding to drug applications. FDA News
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Levoxyl (levothyroxine sodium) Tablets, King Pharmaceuticals, Inc., Labeling Revision
  • Zaditor (ketotifen fumarate) Ophthalmic Solution, Novartis Pharmaceuticals Corp., Labeling Revision
• Warning Letters
  • Clinical Investigation; Nagarjuna R. Ponugoti, M.D.
  • Clinical Investigation; Arturo Corces, M.D.
  • Clinical Investigation; Willa A. Hsueh, M.D.
  • Clinical Investigation; Nagarjuna R. Ponugoti, M.D.

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