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FDAnews Drug Daily Bulletin

Generic Approvals Continue to Speed Forward

July 12, 2017

The FDA approved the most generic drugs during May and June that is has since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early-tenure promises to speed generics to market in an effort to lower U.S. drug prices.

The agency approved 77 generics in May and 88 in June, taking the total for the year to 565. Another 19 were tentatively approved in May, and 12 in June, according to the FDA’s Office of Generic Drugs.

June marked receipt of 67 ANDAs, one more than the previous month and taking the total for the year to 944.

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