Thank you for sharing!

Your article was successfully shared with the contacts you provided.

Drugmaker Wyeth on Wednesday sued regulators at the U.S. Food and Drug Administration in an attempt to block the sale of a recently approved generic version of its intravenous antibiotic Zosyn. In the complaint filed in federal district court in Washington, D.C., by Wyeth’s lawyers at Sidley Austin, the company alleges that the generic is not an equivalent product and could harm critically ill patients. The complaint also names as defendants the U.S. Department of Health and Human Services, Secretary of HHS Kathleen Sebelius, and FDA Commissioner Margaret Hamburg.

Zosyn is an intravenous treatment for bacterial infections. Wyeth claims the drug version that the FDA approved last week for manufacture by India’s Orchid Chemicals & Pharmaceuticals Ltd. is based on an old formulation of Zosyn. The old version reacts with a standard IV solution when they are both administered through the same IV line, according to the complaint. The reaction, the complaint says, inactivates the antibiotic, limiting the dosage that patients would get.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Advance® Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]

Reprints & Licensing
Mentioned in a Law.com story?

License our industry-leading legal content to extend your thought leadership and build your brand.


ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2021 ALM Media Properties, LLC. All Rights Reserved.