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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:
In the US, where a system of quasi-private healthcare is in place, a formulary is a list of prescription drugs available to enrollees, and a tiered formulary provides financial incentives for patients to select lower-cost drugs. For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing ...
GoodRx Holdings, Inc., is an American healthcare company that operates a telemedicine platform and free-to-use website and mobile app that track prescription drug prices in the United States and provide drug coupons for discounts on medications. [3] GoodRx checks drug prices at more than seventy-five thousand pharmacies in the United States.
The AHFS DI is one of several compendiums [1] approved by the Social Security Act (Section 1861(t)(2)(B)(ii)(I)) as a source of off-label anti-cancer drug use. [2] [3] It was originally published in 1959 as the American Hospital Formulary Service (AHFS) by the American Society of Health-System Pharmacists.
Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs. USP-NF standards also have a role in US federal law ; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity.
Lifitegrast was initially designed by Sunesis and developed by SARcode Bioscience [6] which was acquired by Shire in 2013, [7] which submitted a new drug application to the US Food and Drug Administration (FDA) in March 2015. The FDA granted Shire a priority review a month later, and requested additional clinical data, which were supplied in ...
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