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Perrigo Company PLC

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Latest From Perrigo Company PLC

US FDA’s Infant Formula Regulatory Authority Doesn’t Reach ‘All That Needs To Be Fixed’

“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.

Consumer FDA

California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target

Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.

OTC Drugs Legal Issues

Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms

Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.

OTC Drugs US State News

UK Cialis Rx-To-OTC Switch World-First For Sanofi, H2 2023 Launch Planned

The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of products in recent months.

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