We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

I Agree

You are here: Industry Insights > Response Letter

News List

FDA Issues Complete Response Letter for Ryaltris americanpharmaceuticalreview
June 26, 2019
India generic drug manufacturer, Glenmark, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
FDA Issues Complete Response Letter for NDA for Dasotraline americanpharmaceuticalreview
September 03, 2018
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatme