The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Acticlate Tablets, 75 mg and 150 mg, of Almirall, LLC. Doxycycline Hyclate Tablets, 75 mg and 150 mg 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 is indicated as an alternative treatment for certain infections where Penicillin is contraindicated. It is also indicated as an adjunctive therapy for acute intestinal amebiasis and severe acne and for prophylaxis of malaria.
Doxycycline Hyclate Tablets USP, 75 mg and 150 mg have an estimated market size of US$ 17 million for twelve months ending March 2020 according to IQVIA.
Alembic now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from USFDA.
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