Lupin gets tentative US FDA nod for a generic prostate cancer drug

Pharmaceutical company Lupin Ltd.

has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Enzalutamide tablets, a treatment for prostate cancer, the company said on Friday, June 26.

The tentative approval covers Lupin's Abbreviated New Drug Application (ANDA) for Enzalutamide tablets in strengths of 40 mg, 80 mg, 120 mg and 160 mg.

According to the company, the US FDA has found Lupin's 40 mg and 80 mg tablets to be bioequivalent to Astellas Pharma's reference listed drug Xtandi for the approved indications.

In addition, Lupin has received tentative approval for 120 mg and 160 mg strengths, which are not traditionally available for Xtandi tablets and are expected to offer healthcare providers and patients more dosing options.

Tentative approval means the drug has met the FDA's quality, safety and efficacy requirements but cannot be marketed in the US until any existing patent or regulatory exclusivity periods expire.

Mumbai-headquartered Lupin is one of India's largest drugmakers, with operations in more than 100 markets.

The company has 15 manufacturing facilities and seven research centres globally and operates across branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Shares of Lupin closed at ₹2,343.50 apiece on Thursday, June 25, down 1.02% for the day.