Lupin announced tentative USFDA clearance for its abbreviated new drug application for generic enzalutamide tablets indicated for castration‑resistant prostate cancer.
The decision covers 40 mg, 80 mg, 120 mg and 160 mg strengths.
The 40 mg and 80 mg versions are bioequivalent to Astellas’ Xtandi, while the 120 mg and 160 mg tablets are designed to expand available dosing regimens.
Lupin Gets USFDA Tentative Approval for Prostate Cancer Treatment Drug
The tentative approval by the US Food and Drug Administration (US FDA) for the abbreviated new drug application for enzalutamide tablets of strengths 40 mg, 80 mg, 120 mg, and 160 mg
Lupin Gets USFDA Tentative Approval Lupin
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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 treatment of castration-resistant prostate cancer.
The tentative approval by the US Food and Drug Administration (US FDA) for the abbreviated new drug application for enzalutamide tablets of strengths 40 mg, 80 mg, 120 mg, and 160 mg, Lupin said in a regulatory filing.
The USFDA has tentatively approved Lupin's enzalutamide tablets, 40 mg and 80 mg as bioequivalent to 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 with alternative dosing options, the company said.