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Generic Drugs Approval In US Reach Record High In 2019


The U.S. Food and Drug Administration approved an all-time record total of 1,171 generic drugs in fiscal 2019, breaking its previous record of 971 approvals in fiscal 2018. This year's approvals include 935 full approvals and 236 tentative approvals.

A generic drug is a pharmaceutical drug that contains the same chemical substance and performs the same functions as a branded drug that was originally protected by chemical patents. Generic drugs are allowed for sale only after the patents on the original drugs expire.

According to the FDA, generic drugs accounted for about 90 percent of all prescription drug purchases in the U.S. Competition from generic drugs saved the U.S. health care system about $293 billion in 2018 and ensured improved as well as affordable access to medicines.

In addition, the FDA approved 125 applications in 2019 for first generics of medicines that had no generic competition.

First generics are the first approval by the FDA that allows a manufacturer to market a generic drug product in the U.S. The agency considers first generics to be important to public health, and prioritizes review of these submissions.

First generics approved this year include an emergency opioid overdose treatment and drugs to treat conditions such as seizures, breast cancer, pulmonary arterial hypertension, depression and various infections.

The regulator is also approving a higher number of complex generic drugs that are harder to copy and have traditionally lacked competition.

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