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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.
Perrigo's omeprazole and sodium bicarbonate capsules indicated for the treatment of frequent heartburn will bear labeling that has been through several updates since the first PPI became available OTC in 2004.
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