Perrigo Pegs Growth To Initiating OTC Switches, Not Following Brands' NDAs
"A foundation of this business has been," says Perrigo's Americas consumer business chief, Jeffrey Needham, "we are a fast follower. That's been our traditional model. We can't afford to do that going forward." In addition to initiating moving ingredients from Rx to OTC, firm is developing "national better brand" versions of drugs already available OTC.
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Perrigo is latest consumer health firm to note substantially slower flu rates slammed OTC drug sales during 2020 fourth quarter. Its total cough/cold product sales for the year were off $63m on decreases of $34m in the Americas and $29m in its international markets.
Perrigo will launch generics of GSK's OTC Voltaren Arthritis Pain drug later in 2020 following FDA approval of its ANDA. GSK, which received FDA's OTC switch approval in February, still hasn't launched the product or indicated when it will.
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.