Inpharma 1439 - 29 May 2004

Other regulatory news from the USThe US FDA has issued an approvable letter for

anidulafungin [Vicuron Pharmaceuticals] indicatingthat its NDA does not currently support a labeling claimfor the initial treatment of oesophageal candidiasis.1

Inotek Pharmaceuticals’ poly(ADP-ribose)polymerase inhibitor INO 1001 has been designated afast track drug product by the FDA for complicationsassociated with thoracoabdominal aortic aneurysmrepair surgery.2

Docetaxel [Taxotere; Aventis] has been grantedpriority review by the FDA for the treatment of womenwith early-stage operable breast cancer with involvedaxillary lymph nodes.3

The FDA has also granted a priority review to GileadSciences’ combination of tenofovir disoproxilfumarate [Viread] and emtricitabine [Emtriva] for thetreatment of HIV infections.4

1. Vicuron Pharmaceuticals Inc. Vicuron Pharmaceuticals Receives ApprovableLetter from FDA for Anidulafungin For the Treatment of EsophagealCandidiasis Requesting Additional Data. Media Release : 24 May 2004.Available from: URL: http://www.vicuron.com.

2. Inotek Pharmaceuticals Corporation. Inotek Pharmaceuticals AnnouncesDesignation of INO-1001 as a Fast Track Product for Complications associatedwith Thoracoabdominal Aortic Aneurysm Surgery. Media Release : 24 May2004. Available from: URL: http://www.inotekcorp.com.

3. Aventis. Aventis Receives Priority Review Designation for the RegistrationalApplication to Support the Use of Taxotere(R) in Women with Early-StageBreast Cancer. Media Release : 18 May 2004. Available from: URL: http://www.aventis.com.

4. Gilead Sciences. U.S. FDA Grants Priority Review to Gilead’s Fixed Dose Co-Formulation of Viread and Emtriva for HIV; New Product Will Combine TwoAnti-HIV Drugs in One Pill Taken Once Daily. Media Release : 17 May 2004.Available from: URL: http://www.gilead.com.

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Inpharma 29 May 2004 No. 14391173-8324/10/1439-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved