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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In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency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
Crown Labs Spreads Out, GSK Narrows Focus In OTC Skin Care Brand Deal
GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna anti-itch lotion, Zeasorb anti-fungal product, Desenex athlete’s foot treatment and Mineral Ice pain-relieving gel. Deals also helps UK pharma pay for its $5.1bn acquisition of oncology drug firm Tesaro.
P&G's Personal Health Sector Has Merck Consumer Chief As International Head
P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.
Coppertone, Dr. Scholl’s On The Block As Bayer Narrows Consumer Health Focus
Bayer will sell Coppertone sunscreen and Dr. Scholl’s foot care brands to focus on growing its core consumer health brands. Although the plan represents ‘failure” in turning around sales for both brands, it is a ‘sensible’ move, say analysts.
“Lame Duck” Congress Has High Stakes For Pharma Companies
Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US FDA Office of New Drugs.
Amazon's Consumer Health Expansion Comes With Prices Sliced
E-commerce giant expands consumer health footprint in past six months with launches of generic OTC drug product lines at prices in some cases significantly undercutting competitors. Primary Health and SoundHealth OTC drugs range from a few dollars less to about half the cost of brand name equivalents.
VapoCool Adds Menthol To P&G's DayQuil, NyQuil Cough/Cold Remedies
Liquid and caplet DayQuil and NyQuil Severe with VapoCool, also offered in cold/flu formulations, are on retailer shelves ready for the cold season. P&G also increases amount of menthol in its Vicks Severe Medicated Drops sore throat lozenges to mark 125th anniversary Vicks line introduction.
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