US consumers currently don't have access to enough private label/store brand competition for Aleve PM (naproxen/diphenhydramine), FDA decides in granting Apotex its first OTC ANDA approval with Competitive Generic Therapy designation and eligibility for a type of exclusivity unlike any other previously allowed for OTCs.
Apotex Inc. is the first OTC drug firm to take a swing at landing a type of exclusivity the US Food and Drug Administration is granting to encourage development of more generic competition to brand name products.
US consumers currently don't have access to adequate private label and store brand competition for Aleve PM (naproxen sodium 220...
Avista VC acquires OTC CMO Trillium; FDA deputy commissioner Jones to open CRN conference; AG1 founder steps down, COO moves up to CEO; ChromaDex hires general counsel; Ajinomoto, Shiru partner to develop sweet proteins; and change at ingredient provider LBB helm.
Brimonidine tartrate eye drops remain key sales driver among Canadian firm’s consumer health lines with 12% growth in the latest quarter. B+L expects pending launch of preservative-free line extension to sustain Lumify as a driver as generics of original formulation are approved.
Martha Stewart sells supplements on iHerb; Cheribundi partners spread the brand at Paris Games; GoodSport’s latest partner is a Bear; Herbalife-sponsored runner competes in ultramarathons; Dutch researcher joins Unicity science board; and Beacon Wellness adds sales strategy chief.
“Clear Eyes is a perfect example where we're dual-sourced and two facilities don't usually go down at the same time. This was just a quite an anomaly,” says CFO Christine Sacco, noting PCH works with more than 100 contract manufacturers.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
