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Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.
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US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
Agreement with Focus Laboratories includes all Freshkote formulations in multi-dose bottles and single-unit vials to market and commercialize the line worldwide.
Latest consumer health investment was $36m upgrade to a Canadian facility, which by mid-2019 will begin making Voltaren OTC topical gel products. GSK's next move in consumer health divestment is its pending sale of its Horlicks business.
In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency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.
Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.
Excedrin Extra Strength US sales for the 12 months ending Aug. 12 were up 4.07% to $77.2m, but those figures don't include the 12,000 free packages of Excedrin gel tablets consumers ordered during GSK's the Limited Edition promotion. The firm offered Excedrin in packages marked with causes consumers commonly link with headaches: commuting, bad dating and "adulting."
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