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Will the FDA’s OTC Monograph Reform Foster Innovation Including Increased Rx-to-OTC Switch Activity?

After years of the OTC industry and the Consumer Healthcare Products Association working with the FDA to pass long-overdue OTC monograph reform and regulatory modernization, long-sought-after reform is now a reality thanks to the CARES (Coronavirus Aid, Relief, and Economic Security) Act.  The act, which was passed by the U.S. Congress and signed into law by President Donald Trump on March 27, 2020, provides more than $110 million over five years for the FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. Continue reading

Nonprescription Drugs USA

Another Prosperous Year for the Nonprescription Drugs Industry

Recently released data from our Nonprescription Drugs USA study shows that the U.S. nonprescription drugs industry posted moderate growth in 2014, recording revenue growth for the sixth consecutive year. Estimated at $24+ billion at the manufacturers’ level, the market climbs by 1.4% from 2013 to 2014. Out of the seven product classes we track, five posted growth, with upper respiratory, digestive products, and feminine products moving at a faster pace.

Among the key factors supporting the market’s growth are the sales and shares increases from select switch brands, such as Pfizer’s Nexium 24HR, which drove solid growth in the digestive products category, as well as the launch of Sanofi’s Nasacort 24HR, which generated healthy gains in the allergy category.Continue reading

Rx-to-OTC Switches Energize Solid OTC Drug Market Growth

Rx-to-OTC Switches Energize Solid OTC Drug Market Growth

Rx-to-OTC switch brands continue to be major game changers within the OTC market, whether promoting strong gains or causing steep declines. Aided by the launch of Rx-to-OTC switch brand Allegra (Sanofi-Aventis) and strong growth of private labels, allergy relief products grew 16.3% in 2011 to become the fastest growing category on the U.S. OTC drug market, according to the Nonprescription Drugs USA 2011 report by international consulting and research firm Kline & Company. The U.S. OTC drug market posted a gain of 2.4% reaching $21.4 billion in 2011 at the manufacturers’ level.

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The Markets for Excipients in the Middle East, Africa, and Southeast Asia

Excipient Blends: the new frontier in oral pharmaceutical applications.

Excipients are the unsung heroes of the oral solid-dosage-form (OSDF) pharmaceutical industry, seemingly content to remain out of the limelight and let the active ingredients take center stage. Now, a new breed of specially formulated blends could be just what the doctor ordered to help drug makers optimize production and potentially reduce the cost of producing life-saving medications.

Most consumers are completely unaware of the critical role excipients play in delivering the beneficial medicines millions rely on to fight diseases and stay healthy. Yet it is the fillers, binders, disintegrants, lubricants, and coatings that ensure the accurate, timed delivery of drugs required to safely maintain optimum active ingredient levels in our system and give the OSDF drugs we take every day their palpable size, texture, and flavor.Continue reading