Alembic Pharma gets Final USFDA nod for Doxycycline Hyclate Tablets
Doxycycline Hyclate Tablets, 75 mg and 150 mg are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections.;
Vadodara: Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 75 mg and 150 mg.
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.
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