Medindia

X

Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States

Tuesday, July 29, 2008 General News J E 4
Advertisement
PITTSBURGH, July 28 Mylan Inc. (NYSE: MYL) todayannounced that its subsidiary, Mylan Pharmaceuticals Inc., has received finalapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Nisoldipine Extended-release (ER) Tablets, 20mg, 30 mg and 40 mg.

Nisoldipine ER Tablets, indicated for the treatment of hypertension, arethe generic version of Sciele Pharma's Sular(R) ER Tablets, which had annualU.S. sales of approximately $94 million for the 12 months ending March 31,2008, for these three strengths. Mylan's Nisoldipine ER, which is beingshipped immediately, is the first generic version of Sular ER to be introducedin the United States.

Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which arepotential first-to-file opportunities.

Mylan Inc., with a presence in more than 90 countries, ranks among theleading diversified generic and specialty pharmaceutical companies in theworld. The company maintains one of the industry's broadest - and highestquality - product portfolios, supported by a robust product pipeline; owns acontrolling interest in the world's second largest active pharmaceuticalingredient manufacturer; and operates a specialty business focused onrespiratory and allergy therapies.

SOURCE Mylan Inc.
Advertisement


Advertisement

You May Also Like

Advertisement
View All

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions
s
Military Health System Contract Awarded to General...
S
Most Influential Events for Korea's Fine and Speci...