Lupin Receives Approval From U.S. FDA For Doxycycline Hyclate Delayed-Release Tablets USP

Global pharma major Lupin Limited (Lupin) on Monday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application 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, of Mayne Pharma International Pty. Ltd, the company announced through an exchange filing.

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

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S.

Lupin shares

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The shares of Lupin on Monday at 3:00 pm IST were at Rs 1,085.25, up by 8.35 points or 0.78 percent.