Palo Alto Labs voluntarily recalls Aspire36 and Aspire Lite supplements sold nationwide, according to the Port St. Lucie, Fla.-based statement published March 3 by FDA. The agency found the products contained aildenafil in trace amounts and dimethyl sildenafil thione (sulfoaildenafil), a purported analog of sildenafil, a drug used for erectile dysfunction, Palo Alto says. The firm says the prescence of those substances may pose a threat to consumers because the analogue "may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels." The Aspire products are sold as a blister pack containing one liquid capsule or a bottle containing either three or 12 liquid capsules. Consumers may return any unused Aspire products for a full refund to the retail location where it was purchased or to Palo Alto directly if they purchased the product from the firm's Direct Response Program. Palo Alto says it now includes a test for aildenafil and sulfoaildenafil in its production protocols...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.