Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Periostat Tablets, 20 mg of Galderma Laboratories, L.P. (Galderma).
Doxycycline Hyclate Tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. The company has a cumulative total of 119 ANDA approvals (107 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
