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

Sepracor Soltara "not approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA notifies Sepracor on March 6 that the NDA for Soltara (tecastemizole) 15 mg and 30 mg capsules will be found "not approvable." FDA is concerned about phospholipidosis and cardiomyopathy that was observed in animal studies of the antihistamine and wants further assurance "of the absence of any potential for QTc prolongation," Sepracor says. Because of Soltara's long terminal elimination phase, FDA believes safety evaluations were not of sufficient duration and also wants additional "evaluation of tissue concentrations of the drug after prolonged exposure…to quantify the potential for tecastemizole accumulation in target organs." Sepracor hopes to meet with FDA in two to four weeks to discuss what will be required for approval. The worst case scenario, the firm said in a March 7 teleconference, is that Sepracor will have to do a 90-day clinical study, which would take four to eight weeks to analyze and would be followed by a six-month FDA review. The firm is hoping instead to submit reanalysis of study data on 90 mg Soltara, which is three times the dose sought for approval. The NDA had a user fee goal of March 1
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS001831

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