McNeil OTC Recalls Slice $900M From J&J's 2010 Sales

Recalled OTC drugs took a $900 million bite out of Johnson & Johnson's fiscal 2010 sales, including $300 million in the fourth quarter, contributing to what the company and analysts labeled disappointing earnings.

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Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”