Aiming for more copycats of each branded drug, FDA expands generic drug priority reviews
Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever — a trend likely to continue.
The progress comes as FDA commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews.
“Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug,” Gottlieb said in a statement. “Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.