In Brief

J&J agrees to settle shareholder complaint; USPlabs destroys DMAA product; Acura strengthens Nexafed; Abbott nutrition sales drive growth; Re-launches drive Novartis OTC rebound; more news In Brief.

Johnson & Johnson agrees to pay $22.9 million to settle a class-action complaint alleging it misled investors about manufacturing quality-control problems that caused widespread recalls of Tylenol products and other leading OTCs marketed by subsidiary McNeil Consumer Healthcare and led to a consent decree with FDA covering three facilities. According to the proposed settlement filed July 15 in U.S. District Court for New Jersey in Trenton, J&J admits no wrongdoing concerning the claim that the plaintiffs suffered stock losses because J&J executives made misleading statements about the recalls. If approved, the settlement would cover buyers of shares between Oct. 14, 2008, and July 21, 2010. The firm in July 2012 resolved a similar shareholder complaint by agreeing to implement company-wide quality control oversight measures. The firm began returning the recalled products to stores shelves in 2012, and says in its latest earnings statement that its U.S. OTC sales are turning around ([A#05130722007]).

The fight finally goes out of USPlabs LLC, which voluntarily destroyed $8 million worth of DMAA-containing products July 2, FDA...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By 

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

 

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.

More from North America

Cuban: Drugmakers Are More Afraid of PBMs Than Trump

 
• By 

The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By 

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.