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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
The U.S. FDA announced approval of three Rx-to-OTC switches on February 14, 2020. One is GlaxoSmithKline’s OTC version of its topical nonsteroidal anti-inflammatory (NSAID) pain reliever, Voltaren Gel (diclofenac sodium topical gel, 1%). This OTC medication will be indicated for temporary relief of joint pain and stiffness due to the most common type of arthritis,
Oral contraceptives (OCs), known commonly as “the pill,” are prescription medications that prevent pregnancy. The most common brands of OCs contain hormone combinations of estrogen, progestin, and/or progesterone. These products have been used for years and were first launched on the U.S. prescription market in the 1960s. While OCs resulted in a new era of
The U.S. OTC market overall experienced 2.0% growth in 2017 with upper respiratory and topical products classes posting higher than average gains, according to Kline’s Nonprescription Drugs USA 2017 annual market study. “A strong cold and flu season in both Q1 and Q4 of 2017 drove the OTC cold and sinus market up 4.5% from
Companies are being more selective in the Rx-to-OTC switches they pursue, according to new research just published by Kline & Company in the 13th study in its venerable syndicated series, Rx-to-OTC Switch Forecasts USA: Next Frontier. Safety is paramount, and the sophistication of clinical studies required to gain approval has increased the cost burden and
Recently, the U.S. OTC market has been evolving, boosted by more prescription medications moving along the Rx-to-OTC continuum, as well as a number of changes in the market. Laura Mahecha, Industry Manager of Kline’s Healthcare Practice, reveals more about these changes in a recent interview about the trends and challenges affecting the U.S. OTC market.
According to Kline’s Nonprescription Drugs USA study, the U.S. OTC market grew over 3.0% during 2013 to reach $23.5 billion at the manufacturers’ level. Driven by strong sales gains in analgesics, upper respiratory, nutritional, and topical products, the market appears to be showing signs of recovery. This is partly due to the long-awaited rejuvenation of
Infographic representing the U.S. Rx-to-OTC Switch Progression. Download the file here or copy paste the link: http://bit.ly/1cQBmWw
There have been signs recently indicating that the environment is becoming ripe for more Rx-to-OTC switches. Since we last reported on this topic in August 2013, we saw the approval of two additional first-in-class switches in categories that would have been thought of as challenging five years ago. One is the first incontinence medication available
With over half a century of market insights on the U.S. consumer healthcare market, Kline & Company expects that new paradigm shifts in regulations, retail, and technology will create new opportunities for medications to move along the Rx-to-OTC continuum and more growth prospects for the U.S. OTC market. Additionally, with the OTC medication market in
