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Pfizer Lipitor OTC Bid Would Face FDA Evolving On Switch Innovation

 
• By Malcolm Spicer

Pfizer looks to lessons from prior statin attempts and an environment open to new ways to inform consumer decisions as it considers filing for a Lipitor switch, which will depend on the outcome of a large actual use trial.

FDA’s interest in fostering innovation in OTC switches may be the most significant factor working in favor of Lipitor as Pfizer Inc. maneuvers toward a possible attempt to bring the statin to nonprescription status.

Research recommendations and regulatory changes in recent years also contribute to an environment likely to be more open to a...

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More from United States

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and lead several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 
• By Sarah Karlin-Smith and Derrick Gingery

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.

More from North America

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

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

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.