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

Allergan Restasis

Executive Summary

Company receives "approvable" letter for .05% cyclosporine ophthalmic emulsion. The NDA is being reviewed for treatment of moderate to severe keratoconjunctivitis sicca. FDA's Dermatologic & Ophthalmic Drugs Advisory Committee voted against approval July 21, but said that completed extension phases of two U.S. Phase III trials could provide additional evidence of a clinical effect (1"The Pink Sheet" July 26, p. 5)

You may also be interested in...



Allergan Restasis Extension, European Studies Could Support Approval

Completed extension phases of two U.S. Phase III trials of Allergan's Restasis could provide additional evidence of a clinical effect for the dry eye therapy, FDA's Dermatologic & Ophthalmic Drugs Advisory Committee ophthalmic subcommittee said July 21.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
UsernamePublicRestriction

Register

PS034738

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