The latest in a series of FDA concerns
The FDA has put off reconsideration of Impax Laboratories' ($IPXL) Parkinson drug Rytary. While the delay to January is procedural, it will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.
The delay to Jan. 9 came after it made changes to the application, a move that allows for a 90-day delay, according to the San Francisco Business Times. The changes were made after the FDA inspected Impax Laboratories' plant in Taiwan and found it wanting. Actually the FDA has found both of Impax' two manufacturing facilities rife with issues, issuing Form 483's for both the Taiwan plant and its long-troubled Hayward, CA, plant within a week of each other in late July.
Impax had shifted much of the production for Rytary to the Taiwan plant after problems arose in Hayward in 2011, leading to a warning letter. But in late July, the FDA issued the Form 483 for the Taiwan plant which included 7 "inspectional observations, two of which are designated as repeat observations," at the end of a two-week inspection.
That surprised analysts, kind of, because several months earlier, Impax said it was confident enough of its manufacturing to resubmit an application for its investigational drug for Parkinson's, approval of which had been delayed because of the FDA's ongoing concerns.