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Plan B One-Step Makes OTC Debut But Cost Concerns Linger

 
• By Dan Schiff

Teva’s Plan B One-Step launches on retail shelves nationwide and sells for around $50 a dose. Slightly less expensive generic equivalents remain behind the pharmacy counter, though some say FDA may be open to sponsors applying for OTC status with a 17-years-and-older age restriction.

Plan B One-Step’s arrival on retail shelves without an age restriction on sales marks the long-awaited emergence of fully OTC emergency contraception, but some still are dissatisfied with the level of access to the drug and its generic equivalents.

Teva Pharmaceutical Industries Ltd.announced Aug. 7 the nationwide launch of Plan B One-Step (levonorgestrel 1.5 mg) with redesigned packaging...

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More from United States

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Inside Elamipretide’s CRL: Clinical And Surrogate Evidence Deficiencies, And A Path Forward

 
• By Sue Sutter

The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.

Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By Cathy Kelly

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

More from North America

Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
• By Sue Sutter

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.