ANDA Submission Lull Is Now A Trend, As Are Sluggish Approval Numbers

FDA has not received more than 49 ANDAs in a single month since the June 2014 rush.

FDA’s vacation from an elevated level of new ANDA submissions continued through the start of 2015, but so far it has not translated into a dramatic increase in approvals.

Generic sponsors still may be recovering from their massive push to get submissions to the agency last summer ahead of...

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