Lupin Gets USFDA Nod For Generic Antibiotic

Pharma major Lupin Ltd. on Monday said it has received approval from the U.S. health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections.

The approval by the U.S. Food and Drug Administration is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing.

This product will be manufactured at Lupin's Pithampur facility in India, it added.

Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of $9 million in the U.S., the company said citing IQVIA MAT June 2023 data.