Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Bolar's diltiazem

Executive Summary

NDA for generic version of Marion Merrell Dow's Cardizem is withdrawn, the generic firm announces Aug. 6. Bolar says it has notified FDA that it is withdrawing the application for the immediate-release form of the calcium channel blocker "without prejudice." Bolar noted that "questions raised by the FDA with regard to certain portions of the application prepared by Bolar's old management; FDA policies that might require resubmission of the NDA; and the recent approvals of ANDAs for this product make it economically unfeasible to continue to pursue approval." Mylan received a tentative approval in March for diltiazem and MMD has announced a generic licensing agreement with Rugby pending expiration of MMD's ANDA exclusivity on Nov. 5, 1992. Bolar had filed the NDA in 1989 under a joint development agreement with Rorer in the hope of preempting other generic competitors.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021295

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel