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Alembic Pharmaceuticals has received approval for its abbreviated new drug application (ANDA) for Doxycycline Hyclate capsules USP, 50 mg and 100 mg, from the USFDA .
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin Capsules, 50 mg and 100 mg, of Pfizer Inc.
Doxycycline is suggested for a variety of bacterial infections including those caused by several gram-negative as well as gram-positive microorganisms. It is also suggested for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethaminesulfadoxine resistant strains. Furthermore, it may be a useful adjunctive therapy in severe acne and in acute intestinal amebiasis.
