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FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says
In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow. CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.
Latest From Consumer
Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus
Pfizer Consumer Health True To Form Pending Move To JV With GSK
Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK anticipated to close in the second half of 2019. Following 2% growth in 2017, a flat year in 2016 and a dip in 2015, Pfizer's view is confirmed of consumer health as a reliable revenue stream but not a strong growth driver.
Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates
Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.
Poland Kick Starts 2019 With Three Rx-To-OTC Switches
Dr. Kade Enters OTC Dermatology Space With Sirius Acquisition
German firm Dr. Kade moves into the OTC dermatology category with an all-share acquisition of Sirius, which owns and markets the Siriderma Med range of OTC neurodermatitis and psoriasis treatments in Germany and will remain an independent company operating from Monheim am Rhein.
US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals
Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
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