Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.



Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts