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Injunctions Food and Drug Administration (FDA)

Foley & Lardner LLP

FDA Targets GLP-1 Providers with Warning Letters

Foley & Lardner LLP on

On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and...more

Gardner Law

Responding to Letters from FDA

Gardner Law on

There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come to Our Attention” Letter. Any...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #3

Luv N’ Care, Ltd. v. Lindsey Laurain, Appeal Nos. 2022-1905, -1970 (Fed. Cir. Apr.12, 2024) - In this week’s Case of the Week, the Federal Circuit affirmed the district court’s bench trial decision that unclean hands...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

(ACOEL) | American College of Environmental...

Bounty Laws and Citizen Suits

In a jurisprudential pile-up, the Fifth Circuit has become the arena for two simultaneous legal battles that may shape the law of standing and realign federal environmental law. While all eyes are on the U.S. Supreme Court...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2023 #4

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz...more

Hogan Lovells

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

Hogan Lovells on

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | January 2018 #3

House Panel Questions FDA Officials on Food-Recall Audit - One day after the U.S. Food and Drug Administration (FDA) issued draft guidance on proposals to expedite product warnings and recalls, FDA and other health officials...more

Polsinelli

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

Polsinelli on

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

Perkins Coie

Food Litigation Newsletter - February 2013

Perkins Coie on

In This Issue: - Court Rules that Yogurt Dispute Belongs Before the FDA - Conclusory Allegations that Advertising is “False and Misleading” Fail Minimum Pleading Standards - 5-Hour Energy Authorized To Sue...more

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