Alembic Pharma gets USFDA Final nod for Doxycycline Hyclate Tablets
Vadodara: Alembic Pharmaceuticals Limited has 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 travellers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains," Alembic said in a filling
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.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.