Drugs

Evaluate Generic Bicalutamide Manufacturers: Petition

A petition submitted to FDA by Buchanan on behalf of an interested client asks the agency to take several actions involving Intas Pharmaceuticals and Sun Pharmaceuticals, manufacturers of generic forms of the prostate cancer drug Casodex (bicalutamide). The petition says the law firm’s client is raising potential patient safety issues involving the generic drugs made by the two companies.

The petition specifically asks that FDA:

review whether Intas and Sun, both of which it says are under “significant regulatory scrutiny,” can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer population;
with regard to Intas and its marketer Accord Healthcare, take two specified actions based on Intas’ history of FDA compliance issues at multiple manufacturing facilities.
with regard to Sun Pharmaceuticals, based on Sun’s history of FDA compliance issues at multiple facilities, take seven specified actions.

Buchanan says its review determined that the bicalutamide product supply in the U.S. market is presently limited to a small number of manufacturers. The petition addresses the details of product manufactured by two generic manufacturers: (1) Accord, the U.S. commercial arm of Intas, which manufactures bicalutamide tablets at the Intas Gujarat, India, facility; and (2) Sun, which manufactures bicalutamide tablets at its facility at the Dadra/Daman, India, site, Buchanan says.

“In light of the information presented herein,” the petition says, “there is concern that both of these manufacturing sites are operating under serious regulatory concerns that raise questions about the ability to ensure the quality, identity, strength, and purity of bicalutamide tablets supplied to U.S. patients.”

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