A six-month suspension from sale has been handed to 23 ranitidine drugs sold in Australia. The country's regulator has suggested all 23 are facing a permanent ban over patient safety fears.

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.

"We believe that we're going to get this done," but "it's possible that ... language authorizing the collection of user fees is not included in this year's appropriation legislation," says Sen. Bob Casey during HELP Committee's confirmation hearing for FDA commissioner nominee Stephen Hahn.

Perrigo "walked away a little bit" from "a model that worked beautifully," says CEO Murray Kessler at investor conference, "In essence, all we've done over the last year is to put back in place the model that worked so well."

Perrigo "walked away a little bit" from "a model that worked beautifully," says CEO Murray Kessler at investor conference, "In essence, all we've done over the last year is to put back in place the model that worked so well."

Lumify redness relief eye drops nearly doubled in sales between Bausch's second and third quarters and drove 7% organic growth of its global consumer business compared to the year-ago period. The brand has double the market share of its two closest competitors, and the firm plans clinical studies for product extensions to the brand in 2020.

Colgate says ‘premiumization’ of its oral care products in North America should drive improved product mix and pricing; higher-end offerings will include a recyclable Tom’s of Maine toothpaste tube and a Colgate Optic White offering. North American Q3 sales grew 1.2% to $869m.

In petition to Supreme Court, Amarin does not assert it makes any fair trade claim "that could be proved without establishing" an FDCA violation, nor does it dispute that its "claims are ultimately premised on allegations that the FDCA was violated," say DoJ solicitor general and ITC counsel.

Perrigo "walked away a little bit" from "a model that worked beautifully," says CEO Murray Kessler at investor conference, "In essence, all we've done over the last year is to put back in place the model that worked so well."

GSK has launched Flunase in Japan following the switch of fluticasone propionate. JSMI’s Toshi Tominaga gives his assessment of the product’s prospects as an OTC drug.

Swiss confectioner Ricola wants to capitalize on a gap in the UK medicated confectionery market with its new Soothe & Clear line. 

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