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

Lovenox Generics: FDA’s Split Opinion On ANDA Approval Fully Supported By Court

This article was originally published in The Pink Sheet Daily

Executive Summary

The decision will give FDA ammunition for future battles over biosimilar approvals as Sanofi’s suit against the agency is tossed out. The court notes there was a split within FDA over its five-pronged test for active ingredient sameness, which the judge sees as evidence that the issues were carefully weighed.

You may also be interested in...



Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

FDA Heparin Immunogenicity Guidance Addresses ANDA Approvals, Brand Changes

Guidance formalizes five criteria FDA used in making a “sameness” determination for Momenta/Sandoz’s enoxaparin ANDA and lays out an approach to assessing the effect of post-approval NDA changes on a product’s immunogenicity without the need for clinical trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM007836

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