You are here

FDA Says Indiplon Capsules Are Approvable, But Not the Tablets

SAN DIEGO, May 16 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that the Company has received communication from the U.S. Food and Drug Administration (FDA) indicating that the agency has determined that indiplon 5 mg and 10 mg capsules are approvable and the 15 mg XR tablets are not approvable at this time. The FDA indicated that they did not have an opportunity to review all of the information submitted during the NDA review cycles. The Company will accept FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required to move indiplon towards full approval.

"While we are disappointed in the FDA action, we will move forward expeditiously to address FDA's outstanding questions regarding the applications," said Gary A. Lyons, President and CEO of Neurocrine. "We are heartened by the approvable action for indiplon capsules and are dedicated to working with the Agency to expedite response to the action letters."

Source: Neurocrine Biosciences, Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs