Mylan launches first generic of Sciele Pharma's Sular ER
This article was originally published in Scrip
Executive Summary
The US FDAhas approved Mylan Laboratories' ANDA for a generic version of Sciele Pharma's (formerly First Horizon) antihypertensive nisoldipine extended-release tablets, Sular ER, in three dosage strengths, and the generics firm plans to ship immediately. Mylan's product is the first generic version of Sular ER to be introduced in the US, and it follows the expiry in June of the only Orange Book-listed patent for nisoldipine ER. Sular ER had annual US sales of about $94 million through March. Sular ER is designed to achieve similar efficacy with lower doses of Sular.