Mylan Wins Tentative FDA Approval for Blood Pressure Drug

Mylan has announced that its subsidiary, Mylan Pharmaceuticals Inc has received tentative approval from the FDA for its abbreviated new drug application for olmesartan medoxomil and hydrochlorothiazide tablets, 20mg/12.5mg, 40mg/12.5mg and 40mg/25mg.

Olmesartan medoxomil hydrochlorothiazide tablets, indicated for the treatment of high blood pressure, are the generic version of Daiichi Sankyo’s Benicar HCT.

Mylan Pharmaceuticals has previously submitted its original application for this product to the FDA, and believes it is the first company to submit a substantially complete abbreviated new drug application (ANDA) containing a paragraph IV certification.

Under the provisions of the Hatch-Waxman Act, it is anticipated that Mylan Pharmaceuticals will be entitled to 180 days of marketing exclusivity for olmesartan medoxomil hydrochlorothiazide upon FDA approval.

In addition, Mylan Pharmaceuticals has recently received tentative FDA approval for its ANDA for alfuzosin hydrochloride (HCl) extended-release (ER) tablets, 10mg. Alfuzosin HCl ER tablets, indicated for the treatment of an enlarged prostate or benign prostatic hyperplasia, are the generic version of Sanofi Aventis’s Uroxatral ER.