Lupin gets USFDA nod for generic antibiotic
The approval by the USFDA is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets
image for illustrative purpose
New Delhi: Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections.
The approval by the US Food and Drug Administration (USFDA) 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 US, the company said citing IQVIA MAT June 2023 data.
