1. Aurobindo gets USFDA approval to make pills for BP treatment

Aurobindo gets USFDA approval to make pills for BP treatment

Aurobindo Pharma said that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture...

By: | Hyderabad | Published: November 22, 2015 12:28 AM

Aurobindo Pharma said that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market generic version of Pfizer’s Revatio (sildenafil citrate) tablets, used in the treatment of high blood pressure in lungs.

This product is expected to be launched by the fourth quarter of 2015-16. The approved Abbreviated New Drug Application (ANDA) is bio-equivalent and therapeutically equivalent to the reference listed drug product Revatio (sildenafil citrate) tablets 20 mg of Pfizer, the company said in a filing to BSE.

“The approved ANDA is bioequivalent and therapeutically equivalent to Pfizer’s Revatio Tablets 20 mg,” the company said in the filing.

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