Topic
Drug Labeling
96 published works
Drug Injury Watch
Vision Loss Associated With Ozempic, Mounjaro, And Other GLP-1 Drugs
By Tom Lamb
People With Vision Loss Want Warnings Even If Risk Of NAION Eye Injury Is Low (Posted by Tom Lamb at Drug Injury Watch) For more than two years, we have seen numerous medical…
Patent Law Weblog
Hikma v. Amarin at the Supreme Court: The Parties’ Opening Briefs
By Kevin E. Noonan – In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label”…
Food, Drug & Agriculture
Texas Sues Johnson & Johnson and Kenvue Over Tylenol: Scientific Evidence, Regulatory Shifts, and the Future of OTC Drug Labeling
By Dominick DiSabatino, Julian Klein
On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division of Johnson & Johnson, and now in…
The Daily Intake
Supreme Court Declines to Review FDA Labeling Preemption for State Claims
The Supreme Court declined to review (Law360 subscription required) a First Circuit decision affirming dismissal of false advertising and consumer protection claims alleging that McNeil Nutritionals LLC misbranded Lactaid drug…
Drug Injury Watch
Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023
By Tom Lamb
Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction (Posted by Tom Lamb at Drug Injury Watch) In September 2023 the Ozempic (semaglutide) drug label…
Life Sciences Perspectives
Is it Biosimilar or Interchangeable? It Won’t Be Easy to Tell Under FDA’s Latest Draft Labeling Guidance
By Susan Lee|Steven Tjoe|Alison Siedor
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA noted…
Drug & Device Law
Wrinkles In Time In The Acetaminophen ASD-ADHD MDL
Last November, we offered well-deserved criticisms of a really bad MDL-wide preemption decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2022 WL 17348351 (S.D.N.Y. Nov.…
Drug & Device Law
MDL-Wide Preemption Win in Zofran Affirmed
By Bexis
One of the decisions we were looking forward to at the end of 2022 has occurred. In In re Zofran (Ondansetron) Products Liability Litigation, ___ F.4th ___, 2023 WL 128570…
Religion Clause
FDA Approves Label Change for Plan B Emergency Contraceptive: Not an Abortifacient
The U.S. Food and Drug Administration announced on Friday that it has approved a labeling change for the emergency contraceptive Plan B One-Step, sometimes known as the morning-after pill. The…
Health Care and Life Sciences
Adverse Event Reports Not Newly Acquired Information for CBE Label Change
Today’s case is a favorable prescription drug preemption decision making a key holding on newly acquired information and adverse event reporting. It is a one-off case involving the prescription drug…