On December 24, 2008 the US Food & Drug Administration granted tentative approval to Accord Healthcare’s bicalutamide.

Accord is a subsidiary of Intas Pharmaceuticals, Ltd., an Indian company. Accord’s function is licensing and marketing.

According to the FDA, this is the definition of “tentative approval”:

“If a generic drug product is ready for approval before the expiration
of any patents or exclusivities accorded to the reference listed drug
product, FDA issues a tentative approval letter to the applicant. The
tentative approval letter details the circumstances associated with the
tentative approval. FDA delays final approval of the generic drug
product until all patent or exclusivity issues have been resolved. A
tentative approval does not allow the applicant to market the generic
drug product.”

According to drugpatentwatch.com, AstraZeneca’s Casodex was approved in the US Oct 4, 1995. The patent expires Apr 1, 2009.

Regards,

Steve

SOURCE:

FDA Application (ANDA) #078917 for Bicalutamide 50mg oral tablets.

LINKS

Accord Healthcare
“A wholly owned subsidiary and the marketing arm of Intas Pharmaceuticals Ltd., India,” Accord Heralthcare “is engaged in all the licensing related activities and pharmaceutical product trading in various Therapeutic Segments in the regulatory markets.” Accord operates in USA, UK, Spain, Canada, Australia & New Zealand, South Africa, Brazil, Mexico, Peru, Vietnam, and Kenya. In the US, Accord’s product registration list includes Simvastin (for hypertension), Pravastin (cardiovascular), Bicalutamide and Finasteride, and anticancer chemotherapy drugs Etoposide, Gemcitabine, Mitomycin and Paclitaxel.

Intas Parmaceuticals, Ltd.