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.
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