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

Another Novartis product delay

Executive Summary

Novartis plans to start additional studies for iloperidone in the fourth quarter to facilitate regulatory review of the schizophrenia drug. Studies will investigate once-a-day dosing and will include at least one switch study from comparator agents. Data from the six-week active phase studies will be included in the NDA submission planned for the fourth quarter of 2002. Novartis' previous timeline for NDA submission was the fourth quarter of 2001 (1"The Pink Sheet" Oct. 23, 2000, In Brief). The brand name for iloperidone will also be changed from Zomaril in response to FDA's concerns about possible confusion with another product: Novartis says "Zom" will still be part of the prefix. Novartis is developing the drug in collaboration with Titan

You may also be interested in...



Novartis Zomaril NDA Filing Awaits More Data On QTc Prolongation

Novartis is conducting additional trials to determine whether the antipsychotic iloperidone has a dose-dependant QTc prolongation side effect before it files an NDA for the agent.

Novartis Zomaril NDA Filing Awaits More Data On QTc Prolongation

Novartis is conducting additional trials to determine whether the antipsychotic iloperidone has a dose-dependant QTc prolongation side effect before it files an NDA for the agent.

Novartis Zomaril

Schizophrenia drug iloperidone shows "at 16 mg level a significantly different efficacy level as compared to placebo," Novartis said during an Oct. 11 teleconference. "The Pink Sheet" (Oct. 16, p. 14) incorrectly reported that the comparator agent in the trial was J&J's Risperdal. Novartis licenses Zomaril from South San Francisco-based Titan Pharmaceuticals. "Novartis' timeline for NDA submission for Zomaril is fourth quarter 2001," Titan said

Related Content

UsernamePublicRestriction

Register

PS038239

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