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Actavis’ Bioequivalence Data Still Missing For Bupropion XL

 
• By Sarah Karlin-Smith

Could the nearly five-month delay in submitting FDA mandated bioequivalence tests signal something is wrong with its two 300 mg bupropion generics?

Allergan PLC refuses to comment on what has caused a five-month-and-counting delay on FDA-required bioequivalence testing for its two 300 mg generic versions of GlaxoSmithKline PLC’s antidepressant WellbutrinXL (bupropion), opening the door to questions as to whether the company is simply late or whether there may be equivalence problems lurking for the drugs.

FDA requested the bioequivalence tests in 2012 after it determined that the 300 mg bupropion generic formally marketed by Teva Pharmaceutical Industries Ltd. and manufactured by Impax Laboratories...

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More from United States

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.