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Consumer Drugs

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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In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency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.

Prescription To Otc Switch Drug Approval Standards United States
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Australian Competition Watchdog Probes GSK/Pfizer Consumer Health JV Proposal

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

M & A Regulation

Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus

Moberg had been expanding its OTC portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine indicated for fingernail and toenail fungus. But $155m agreement with two investment groups will complete Moberg's divestment of consumer health brands.
OTC Drugs Consumer

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.

Consumer OTC Drugs

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.

Consumer Legal Issues

Poland Kick Starts 2019 With Three Rx-To-OTC Switches

Clotrimazole, pyrantel, and ciclopirox olamine have been switched from prescription-to-OTC status by Poland's national drug regulator.
Poland Prescription To Otc Switch

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.

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