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Keeping Track: Busy August Ends With Approval For Doravirine, CRLs For Dasotraline And Waylivra

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

The US FDA's Center for Drug Evaluation and Research (CDER) topped off its torrid August with an approval for Merck & Co. Inc.'s non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine, bringing the US FDA's novel drug approval count for the year to 34.

Slowing the growth of the total, however, was the issuance of complete response letters (CRLs) for Sunovion Pharmaceuticals Inc.'s dasotraline and Akcea Therapeutics Inc.'s Waylivra (volanesorsen).

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