Lupin gets US FDA approval for generic version of Doxycycline Hyclate tablets

The product will be manufactured at Lupin’s Pithampur facility in India.

Pharma major Lupin on August 14 announced that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets.

The approval is for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed-Release Tablets, 60 mg and 120 mg, Lupin said in an exchange filing.

According to a regulatory filing, this product will be manufactured at Lupin’s Pithampur facility in India.

Doxycycline Hyclate Delayed-Release Tablets USP had estimated annual sales of $9 million in the US.

Lupin shares ended at Rs 1,081 a piece on the BSE on August 14, up 0.38 percent from its previous close.

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