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

Cipher isotretinoin "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cipher's CIP-isotretinoin is "approvable" May 1, with FDA requesting additional clinical data and further chemistry, manufacturing and controls details, the company says May 2. The firm believes "the data is on hand," but cautions that "we cannot rule out the possibility that a further clinical trial will be required." Cipher characterizes the approvable decision as "encouraging." FDA initially had refused to file the application (1Pharmaceutical Approvals Monthly September 2005, In Brief). Cipher claims its formulation of the retinoid has food effect advantages over Roche's Accutane and generic isotretinoins...

You may also be interested in...



Cipher CIP-isotretinoin regulatory path

Cipher plans to meet with FDA to determine whether its CIP-isotretinoin acne product should be filed as a 505(b)(2) NDA or as an abbreviated application, the firm says Sept. 6. FDA is questioning the validity of the 505(b)(2) pathway "since they consider [the formulation] eligible for submission as an abbreviated new drug application," Cipher states. The company submitted the NDA, which it maintains should be a 505(b)(2) application, in the second quarter but FDA deemed the filing unacceptable in its current form. Cipher is pointing to food effect advantages with its isotretinoin formulation compared to Roche's Accutane brand and the three other branded generic versions of the retinoid to argue for regulation as a new product, not a generic...

FTC Commissioner Changes Could Impact Pharma Mergers, Scrutiny Of Biosimilars Uptake

President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.

Prices Plunge As Xarelto Generics Arrive In India

More than half a dozen generic rivaroxaban brands are now available in India, putting the heat on Bayer’s blockbuster anticoagulant Xarelto in the price-sensitive market. Many rival generics are priced over 50% lower than the innovator product.

Topics

UsernamePublicRestriction

Register

LL1135489

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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