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FDA Bioequivalence Study On Metoprolol Shows Emerging Generic Investigation Strategy

 
• By Brenda Sandburg

Outside research project launches after FDA does not find a safety signal in its internal investigation into generic versions of AstraZeneca’s Toprol XL.

FDA’s assessment of potential bioequivalence and therapeutic equivalence problems with generic extended-release metoprolol products shows that the agency appears to be settling into a pattern for investigating these kinds of concerns, but is not using a single fixed script each time.

“Therapeutic inefficacy and adverse events have been reported by physicians and patients switching from brand to generic metoprolol extended release...

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More from United States

Non-Opioid Analgesics Guidance On Chronic Pain: One Trial Plus Confirmatory Evidence May Be Enough

 
• By Laura Helbling

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

Under Trump, Antitrust Regulators May Be More Divestiture Friendly

 
• By Tim Casey

The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

More from North America

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

Galderma’s Post Hoc Analysis Supports Nemluvio Claims But Clearer Disclosures Needed, NAD Says

 
• By Cathy Kelly

Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.

Former CBER Director Peter Marks Brings Genetic Medicines Street Cred To Lilly

 
• By Jessica Merrill

FDA’s former CBER director is joining industry as senior VP of molecule discovery and head, infectious disease at Eli Lilly.