Valeant Pharmaceuticals (NYSE:VRX) today announced that the Food and Drug Administration (the FDA) has entered an administrative order â€œin the public interestâ€ to stay the approval of generic fluorouracil cream 5% until May 30, 2008 â€œbecause there are outstanding questions regarding this approval that the Agency must consider.â€ The FDA hopes to conclude its review by May 30, 2008 and Spear has agreed to an administrative stay of its ANDA approval until May 30, 2008. According to the administrative order by the FDA, signed by Associate Commissioner for Policy and Planning, Jeffrey Shuren, â€œmarketing, sales and shipment under ANDA 77-524 are prohibited during the pendency of this administrative stay.â€
On April 11, 2008, the FDA approved an Abbreviated New Drug Application (ANDA) for a fluorouracil cream 5% sponsored by Spear Pharmaceuticals. On the same day, the FDA responded to Valeantâ€™s December 21, 2004, Citizen Petition regarding potential generic versions of Valeantâ€™s pioneer drug product, EfudexÂ® (fluorouracil) Cream 5%. Efudex Cream 5% is approved by the FDA for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical. In the Citizen Petition, Valeant requested that the FDA decline to approve generic versions of Efudex Cream 5% where the generic company has failed to provide test data comparing the generic product to Efudex Cream in patients diagnosed with superficial basal cell carcinoma, a form of skin cancer.
On April 25, 2008, Valeant filed a federal lawsuit against the Secretary of Health and Human Services, Michael O. Leavitt, and the Commissioner of the FDA, Andrew C. von Eschenbach, M.D., challenging the FDAâ€™s denial of Valeantâ€™s Citizen Petition and the approval of a generic to Efudex Cream 5%. Valeant requested a temporary restraining order (TRO) to suspend the FDAâ€™s approval of Spearâ€™s ANDA. Following an initial round of briefing, the FDA requested and obtained from the court a two week stay of the proceedings. In addition, Spear Pharmaceuticals committed to the court that it would suspend all further sales and shipment of its product for the duration of the initial stay. The FDA has since filed documents in the case indicating that in reviewing its files, the FDA has identified an issue in the Spear ANDA â€œconcerning whether FDA has required submission of all necessary and appropriate scientific information in support of approval of Spearâ€™s ANDA.â€ Now the FDA has issued an â€œAdministrative Reconsideration and Stay of Actionâ€ of the Spear ANDA and Spear has agreed to this stay of the ANDA approval by the FDA.
Important Safety Information
EfudexÂ® (fluorouracil) Topical Solutions and Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
Efudex is contraindicated in women who are, or may become, pregnant during therapy because of potential hazards to the fetus. Cases of miscarriage and birth defects have been reported in women who are pregnant.
The most frequent adverse events occur locally and may include itching, burning, soreness, tenderness, scaling, and swelling. Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. For complete Prescribing Information, please visit www.efudex.com.
Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Efudex is a registered trademark of Valeant Pharmaceuticals International or its related companies. For information on Efudex visit www.efudex.com.
This press release contains forward-looking statements, including, but not limited to, statements regarding the companyâ€™s legal case against the FDA and the filing of a temporary restraining order against Spear Pharmaceuticals and other risks detailed from time to time in the companyâ€™s SEC filings. The company cautions the reader that these factors, as well as other factors described in its SEC filings, are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. The company also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this press release. The company undertakes no responsibility to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Laurie W. Little, 949-461-6002