28th June 2024, Mumbai: Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, of Galderma Laboratories, L.P. (Galderma).
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Refer label for a detailed indication. Doxycycline Capsules, 40 mg have an estimated market size of US$ 123 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 205 ANDA approvals (179 final approvals and 26 tentative approvals) from USFDA.