FDA Approves Sicor’s Mesna Cancer Injection

Sicor Inc., an Irvine specialty pharmaceutical company, said its Gensia Sicor Pharmaceuticals unit received Food and Drug Administration approval to market its mesna injection to treat testicular cancer.

Sicor’s product has been the subject of a patent squabble between Sicor and the innovators of the product.

Bristol-Myers Squibb Co. currently markets the Ifex/Mesnex injection kit for the treatment of testicular cancer, while Asta Medica markets the Mesnex injection. Both companies had filed a patent infringement lawsuit against Sicor on one patent related to mesna, the generic name of Mesnex.

Bristol-Myers and Asta Medica weren’t immediately available for comment.

Sicor said in a press release that its original abbreviated new drug application was amended because the innovator listed an additional patent. However, an FDA administrative review determined that the new patent was not listed in a timely manner and that Gensia Sicor didn’t have to file an amended application.

Sicor stock gained $1.11, closing at $14.91 a share on Nasdaq.