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Alembic’s Doxycycline capsules receives US FDA approval

expressbpdAugust 01, 2017

Tag: Alembic , Doxycycline capsules , FDA Approval

 

Alembic Pharmaceuticals has received the United States Food and Drug Administration (US FDA) approval for Abbreviated New Drug Application (ANDA) of anti-bacterial Doxycycline capsules USP 75 mg and 100 mg.

The approved ANDA is therapeutically equivalent to a reference listed drug product Monodox capsules, 75 mg and 100 mg of Aqua Pharmaceuticals. Doxycycline capsules are used in the treatment and prevention of infections that are proved or strongly suspected to be caused by bacteria.

According to IMS December 2016 data, Doxycycline capsules had an estimated market size of $30 million. The company now has 62 ANDA approvals from the US FDA.

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