The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.
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Earlier Event: June 20Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Later Event: July 31Psychopharmacologic Drugs Advisory Committee