Friday, 20 April 2018

Aurobindo receives USFDA approval for Drospirenone and Ethinyl Estradiol tablets


This drug, in both the formulations should add $8-10mn in Aurobindo's annual revenue.
Aurobindo Pharma has received USFDA approval for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg, 0.03 mg. It is a generic version of Yaz tablets (an oral contraceptive) of Bayer Healthcare Pharmaceuticals Inc. The company in February received approval for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.02 mg.

As per Bloomberg, Yaz (brand and generic) reported annual sales of $481mn in 2017. Apart from the brand, there are nine other companies selling this drug and Aurobindo is the latest entrant. Glenmark, in 2016 and Lupin, in 2012 received final approvals for their ANDAs and have commercialized this drug. This drug (Drospirenone and Ethinyl Estradiol) in both the formulations, should add $8-10mn annually in Aurobindo’s revenue, and hence, it is a positive on the stock.

Source:
https://www.indiainfoline.com/article/news-top-story/aurobindo-receives-usfda-approval-for-drospirenone-and-ethinyl-estradiol-tablets-118040200003_1.html