Latest Aleve PM Copy Could Have 180-Day Exclusivity From More Competition
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.
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OTC Private Label, Rx Generics Firm Apotex To Be Acquired By Private Investment Group
SK Capital announced agreement to acquire Apotex, saying it will invest to “support Apotex’s next phase of growth and continued innovation for patient affordability."
Strides Pharma Reaches 9 US OTCs With Naproxen
Recent approval of Indian firm’s ANDA for 220-mg naproxen capsules comes as NDA process for launching OTCs in US soon could take a back seat to overhauled monograph program the pharma industry prepares to start using on 1 October.
US Health Market In 2019: Unfinished Business Leaves Lasting Impression
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.