Pink Sheet is part of the Business Intelligence Division 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

Amphastar Seeks Court Order Requiring FDA To Approve Its Enoxaparin ANDA

Executive Summary

Amphastar’s initial lawsuit against FDA achieved its stated goal: the agency released two shipments of raw heparin material the company is to use in producing generic Lovenox (enoxaparin).
Advertisement

Related Content

Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid
FDA Hit With Slew Of Suits As Firms Fight For Market Advantage
Generic Lovenox Battle Heats Up With Amphastar’s ANDA Approval
Generic Lovenox Battle Heats Up With Amphastar’s ANDA Approval
New Delay For Teva's Generic Lovenox Bodes Well For Sandoz/Momenta Sales
Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off
Lovenox Lawsuit May Be Omen For Biosimilar Battles
Sandoz Sues FDA For Inaction On Omnitrope NDA

Topics

Advertisement
UsernamePublicRestriction

Register

PS052976

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