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Consumer Drugs

Set Alert for Consumer Drugs

Rulemaking For OTC Switch Process Changes Pushed To 2019

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.

Consumer Drug Approval Standards Consumer
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Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

 

Dermatology Consumer

OTC Private Labelers Recall CVS, Walmart Brand Products

Recalls include one lot of CVS Health Sinus Relief manufactured by Product Quest Manufacturing, Walmart's Equate laxative made by Lupin's US office and 12 cough and cold products marketed under Preferred Plus Pharmacy and other private label brands and made by RIJ Pharmaceutical Corp. Chart provides update on recent US OTC recalls.

Consumer Recalls

Bausch Health Boosts Ad Spending For Expanding OTC Eye Care Lineup

"We're investing more to drive growth as we allocate capital to support the launches of new products in the segment like Lumify, for DTC advertising that continue to drive sales growth of other US consumer products like our eye vitamins," says CEO Joseph Papa.

Consumer Ophthalmic

Perrigo's OTC Core Could Expand To Include National Brands

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Prescription To Otc Switch Advertising, Marketing & Sales

UK OTC Group Chief Outlines Cautious Brexit Stance

Proprietary Association of Great Britain urges UK and EU to “ensure appropriate mutual recognition agreements are in place” following UK's Brexit withdrawal, says chief executive John Smith.

United Kingdom Consumer

US FDA's Sunscreen Progress Gets Dim Review From Congressional Appropriators

House and Senate appropriators' take note that US FDA has not approved an additional OTC sunscreen ingredient since the 2014 passage of the Sunscreen Innovation Act.

Consumer Legislation
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