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

Court Backs FDA Rationale For Approving Generic Lovenox

This article was originally published in The Pink Sheet Daily

Executive Summary

A Washington, D.C. district court judge says FDA had the right to request additional immunogenicity tests of Sandoz's generic in denying Sanofi-Aventis's request to overturn approval of the drug.

You may also be interested in...



New Delay For Teva's Generic Lovenox Bodes Well For Sandoz/Momenta Sales

A "minor deficiency letter" from FDA's Office of Generic Drugs seeks responses to questions about Teva's enoxaparin ANDA, the company says.

New Delay For Teva's Generic Lovenox Bodes Well For Sandoz/Momenta Sales

A "minor deficiency letter" from FDA's Office of Generic Drugs seeks responses to questions about Teva's enoxaparin ANDA, the company says.

Momenta, Sandoz Play Patent Defense For A Change, Seek Injunction To Prevent Teva From Launching Generic Lovenox

Firms claim Teva, which now seems close to approval, cannot manufacture enoxaparin to match Sanofi's branded Lovenox without infringing Momenta's manufacturing process.

Topics

UsernamePublicRestriction

Register

LL1129367

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