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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:
The Act also requires the drug innovator to give the FDA the numbers of patents it believes cover its drug; the FDA does not evaluate whether the patents cover the drug, but publicly lists them in the Orange Book, and these are the patents the life of which is extended if there are regulatory delays. [5]
The Food and Drug Administration's update of its Orange Book added the drugs approved last month, including VIVUS' (NAS: VVUS) Qsymia and Onyx Pharmaceuticals' (NAS: ONXX) Kyprolis. But the entry ...
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
The regulator approved the drug for moderate to severe obstructive sleep apnea in adults with obesity, the company said. ... The FDA's approval is based on data from two trials involving 469 ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
They specialize in developing drugs for the treatment of cancer. Merrimack's first FDA-approved drug was approved in 2015; Onivyde, a liposome encapsulated version of irinotecan is used for treating pancreatic adenocarcinoma. It was approved for use in the European Union the following year. [1] [2]