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OTC Switch Interest Cooled By Study Costs To Update Safety Data

Executive Summary

Firms often are hesitant to prepare Rx-to-OTC switch applications because safety and efficacy data for their products are over a decade old, notes health care consultant Laura Mahecha.

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Cough/Cold, Analgesic Patch Sales Ease Pain Of Private Label Growth In OTCs

Topical analgesic sales grew double digits in 2017 on innovation and adhesive patch launches, helping drive 2.1% growth of US manufacturers' OTC drug sales in 2017 to $21.2bn, Kline & Co. independent consultant Laura Mahecha says. But private label continues to outpace branded product sales growth.

Cough/Cold, Analgesic Patch Sales Ease Pain Of Private Label Growth In OTCs

Topical analgesic sales grew double digits in 2017 on innovation and adhesive patch launches, helping drive 2.1% growth of US manufacturers' OTC drug sales in 2017 to $21.2bn, Kline & Co. independent consultant Laura Mahecha says. But private label continues to outpace branded product sales growth.

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Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.

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