Alembic Pharma gets US FDA nod for generic Doxycycline Hyclate tablets

Drug firm Alembic Pharmaceuticals said it has received nod from the US health regulator for generic Doxycycline Hyclate tablets used for the treatment of several types of infections among others. The company has received final approval from the United States Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate tablets USP, in the strengths of 75 mg and 150 mg, Alembic Pharma said in a BSE filing.

The company’s product is a generic version of Almirall’s Acticlate tablets in the same strengths, it added.

Doxycycline Hyclate tablets USP, 75 mg and 150 mg have an estimated market size of USD 17 million for 12 months ending March 2020, Alembic Pharma said.

The tablets are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections. It is also indicated for anthrax including inhalation anthrax, it added.

The drug is also used as an alternative treatment for certain infections where penicillin is contraindicated. It is also indicated as adjunctive therapy for acute intestinal amebiasis and severe acne and for prophylaxis of malaria, Alembic Pharma said.

The company now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from the US FDA, it added.

Shares of Alembic Pharmaceuticals were trading at Rs 918.35 per scrip on the BSE, up 0.54 per cent from its previous close.