New Delhi: Drug firm Lupin has received approval from the US health regulator to market its generic Doxycycline hyclate tablets, used for the treatment of infections, in the American market.
The company has received final approval from the United States Food and Drug Administration (US FDA) to market its Doxycycline hyclate tablets USP in the strength of 100 mg, Lupin said in a BSE filing.
The company’s product is a generic version of Pfizer Inc’s Vibra tablets in the same strength, it added.
As per IMS MAT June 2017 data, Doxycycline hyclate tablets USP in 100 mg strength had US sales of USD 149.9 million, Lupin said.
The tablets are indicated for the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne, it added.