Alembic Pharmaceuticals Receives USFDA Approval for Doxycycline Hyclate Capsules

Alembic Pharmaceuticals Limited announced that the company has received approval from the USFDA approval for its ANDA for Doxycycline Hyclate Capsules USP, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin Capsules, 50 mg and 100 mg, of Pfizer Inc. Doxycycline is indicated for a wide variety of bacterial infections including those caused by several gram-negative as well as gram-positive microorganisms. Doxycycline is also indicated for prophylaxis of malaria due to Plasmodium falciparum in short-term travelers to areas with chloroquine and/or pyrimethaminessulfadoxine resistant strains. Doxycycline may be a useful adjunctive therapy in severe acne and in acute intestinal amebiasis. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, have an estimated market size of USUSD 80 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from the USFDA. – Medical Buyer Bureau