Alembic Pharmaceuticals announces USFDA Final Approval for Doxycycline Hyclate Tablets USP, 100 mg

Monday May 25, 2020 at 12:11 pm

Alembic Pharmaceuticals Limited (Alembic) announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP 100mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vibra-Tabs, 100mg of Pfizer, Inc. Doxycycline Hyclate Tablets USP 100mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. It is also indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. Doxycycline Hyclate Tablets 100mg has an estimated market size of US$ 53 million for twelve months ending December 2019 according to IQVIA. Alembic has a cumulative total of 121 ANDA approvals (108 final approvals and 13 tentative approvals) from USFDA.

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