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J&J’s Mylanta, Mylicon Lines Return Via ‘Fixed-Term’ License With Infirst

 
• By Malcolm Spicer

Unlike other OTC deals J&J made since McNeil Consumer Healthcare’s quality-control problems led to widespread recalls and a consent decree with FDA, the firm is not divesting the digestive health lines. Infirst will manufacture and market the products in the U.S. for an undisclosed period before the brands return to McNeil.

Johnson & Johnson’s Mylanta and Mylicon brands return to the market in a “fixed-term” licensing with infirst Healthcare Ltd. sooner than J&J’s consumer products business could manage under manufacturing limits imposed by FDA.

Unlike other OTC brand deals J&J made since quality-control problems at its McNeil Consumer Healthcare business led to widespread recalls, including the Mylanta and Mylicon lines, starting in 2009 led to a 2011

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More from United States

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• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

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• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

More from North America

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• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.