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Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, [1] as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
It was approved for medical use in the United States and in the European Union in 1998. [5] [8] [11] [12] In 2022, it was the 157th most commonly prescribed medication in the United States, with more than 3 million prescriptions. [13] [14] It is available as a generic medication. [15] [16] In the United Kingdom, it is available over-the-counter ...
Products made by Nature Made, CeraVe and Neutrogena had the most No. 1 rankings.
Merck's over-the-counter products includes cough and cold remedies, diet supplements, everyday health supplements, and women's and children's health products. Europe accounts for around 65% of the global sales, 32% is made in Emerging Markets and 3% is achieved elsewhere. [3] In April 2018, P&G agreed to buy Merck Consumer Health for $4.2 ...
The Consumer Healthcare Products Association, a group that represents over-the-counter drug manufacturers, said it is against removing oral phenylephrine from the market, adding that it is the ...