Alembic Pharmaceuticals has obtained final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, seventy five mg and 150 mg. The accepted ANDA is therapeutically equivalent to the reference listed drug product (RLD), Acticlate Tablets, seventy five mg and 150 mg, of Almirall, LLC. Doxycycline Hyclate Tablets, 75 mg and one hundred fifty mg are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections. It is likewise indicated for anthrax along with inhalation anthrax. It is indicated as an opportunity remedy for sure 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 one hundred fifty mg have an estimated marketplace length of US$ 17 million for 365 days finishing March 2020 according to IQVIA.
Alembic now has a complete of a hundred twenty five ANDA approvals (111 very last approvals and 14 tentative approvals) from USFDA.
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