Pharma Major, Alembic Pharmaceuticals on Thursday said the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules USP, 50 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin Capsules, 50 mg and 100 mg, of Pfizer Inc., the company said in a filing with BSE. Doxycycline is indicated for a wide variety of bacterial infections including those caused by several gram-negative as well as gram-positive microorganisms. Doxycycline is also indlcated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (< 4 months) to areas with chloroquine and/or pyrimethaminesulfadoxine resistant strains. Doxycycline may be a useful adjunctive therapy in severe acne and in acute intestinal amebiasis.
Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, have an estimated market size of USD 80 million for twelve months ending December 2017 according to IQVIA.
Alembic now has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA.
UNI JS NV AE 1357
-- (UNI) -- C-1-DL0169-1402342.Xml