Lupin gets USFDA tentative approval for generic prostate cancer drug

Lupin Ltd has received tentative approval from the USFDA for its generic enzalutamide tablets used to treat castration-resistant prostate cancer. The approval covers four dosage strengths, including 120 mg and 160 mg variants, offering healthcare providers and patients more dosing options

New Delhi: Homegrown pharma major Lupin Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of enzalutamide tablets indicated for the treatment of castration-resistant prostate cancer.

The tentative approval from the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for enzalutamide tablets in strengths of 40 mg, 80 mg, 120 mg and 160 mg, Lupin said in a regulatory filing.

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The USFDA has tentatively approved Lupin’s enzalutamide tablets in 40 mg and 80 mg strengths as bioequivalent to the Reference Listed Drug (RLD), Xtandi tablets, of Astellas.

While Xtandi tablets are traditionally available in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths will offer healthcare providers and patients alternative dosing options, the company said.