Pink Sheet is part 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

Future unclear for Impax Parkinson’s drug

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Impax Laboratories is evaluating options for its Parkinson's disease candidate Vadova (carbidopa/levodopa) after receiving its second "not approvable" letter from FDA, the firm announces Jan. 30. According to the company, "FDA's action is primarily based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa." Bristol-Myers Squibb markets a controlled-release carbidopa/levodopa as Sinemet CR. "We will continue to pursue discussions with FDA concerning this decision and we are evaluating all options for the product," Impax CEO Larry Hsu said. The first "not approvable" letter was issued over concerns with clinical pharmacology and chemistry, manufacturing and controls, which Impax said were successfully resolved and were not cited in the second letter...
Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS003770

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