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Wednesday, March 27, 2019

Lannett gets FDA approval for Aspirin and Dipyridamole capsules ANDA

Lannett announced that it received approval from the FDA of its abbreviated new drug application, or ANDA, for Aspirin and extended-release Dipyridamole capsules, 25 mg/200 mg, the therapeutic equivalent to the reference listed drug, Aggrenox capsules, 25 mg/200 mg, of Boehringer Ingelheim Pharmaceuticals. Total U.S. sales of Aspirin and extended-release Dipyridamole capsules, 25 mg/200 mg, was approximately $174.6M for the 12 months ended January, according to IQVIA, although actual generic market values are expected to be lower.

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