Lupin gets USFDA approval for oral contraceptive

Indo Asian News Service

New Delhi, Sep 27 (IANS) Pharma major Lupin has received the US health regulator's approval to market a generic version of Warner Chilcott Company's 'Ovcon 35' tablets, an oral contraceptive, in the American market, the company said Friday.

The Mumbai-based company has received final approval for its VyfemlaTM Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg) from the US Food and Drugs Administration (USFDA).

"Lupin's US subsidiary Lupin Pharmaceuticals Inc (LPI) shall commence marketing the product shortly," Lupin said in a statement.

The oral contraceptive (OC) market in the US is valued at around $5 billion and is growing at around 8 percent annually.

According to IMS MAT March sales data, Warner Chilcott Company's Ovcon 35 tablets had annual US sales of around $22.3 million.

Lupin entered the OC space in the US market in September 2011 and currently has one of the largest OC pipeline for the US market, with 34 filings and 14 approvals so far.