The U.S. Food and Drug Administration approved several products as the first generic drugs to be granted a Competitive Generic Therapy (CGT) designation, which aims to accelerate the development and review processes for generic drugs that lack competition, the FDA announced Wednesday.
“This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need,” FDA Commissioner Scott Gottlieb said in the FDA press release.
The newly approved products are variations of potassium chloride oral solution that fight low potassium levels in the bloodstream for patients on diuretics.
The FDA has new powers to grant drugs CGT designations thanks to the FDA Reauthorization Act of 2017. Drugs can be designated as CGT if there is “inadequate generic competition for that drug, meaning there is not more than one approved drug” in the FDA’s Orange Book of approved drugs, according to the release.
If a drug receives a CGT designation, its maker can get “marketing exclusivity” for approximately six months. That is only possible if no one else is making the drug and the maker gets it to the market within 75 days, or approximately two and a half months.
CGT drugs must “demonstrate that all aspects of their drug product meet the FDA’s rigorous approval standards” during the expedited process, according to the release.
“Today’s approval of the first generic drug to receive a Competitive Generic Therapy designation reflects [the FDA’s] commitment to lower cost options and more competition that puts American patients first,” Department of Health and Human Services Sec. Alex Azar wrote on Twitter Wednesday. (RELATED: Trump Administration Requires Hospitals To Post Standard Prices Online)
Today’s approval of the first generic drug to receive a Competitive Generic Therapy designation reflects @US_FDA‘s commitment to lower cost options and more competition that puts American patients first. https://t.co/6aqh4XC6il
— Alex Azar (@SecAzar) August 8, 2018
Generic drugs are off-brand copies of drugs that are no longer patented. Drug patents can last for 20 years and be extremely lucrative for drugmakers, according to Truveris. Drugmakers spend billions each year to build up customer bases for their brand drugs so that when their drugs go off-patent, cheaper generics do not steal their market.
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