According to Luitpold Pharmaceuticals, its suspension of both manufacturing at its Shirley, NY facility and distribution of products manufactured at that location, will not affect Sprix ketorolac tromethamine nasal spray. The company says that it voluntarily stopped production prior to an April 14 meeting with the FDA to follow up on recent inspections and agreed to suspend distribution after the meeting.
Luitpold acquired Sprix in December, 2010 when it purchased Daiichi Sankyo subsidiary Roxro, and the product is manufactured at a facility unaffected by the shutdown. The FDA approved Sprix for the short‐term management of acute moderate-to-moderately severe pain in May 2010.
Read the Luitpold press release.
