The Food and Drug Administration Dec. 23 released a draft guidance for industry on bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for generic versions of Quillivant XR (methylphenidate HCL extended-release oral suspension).
A notice announcing the draft guidance was published in the Dec. 24 Federal Register (79 Fed. Reg. 77,515).
Quillivant XR, which is made by New York-based Pfizer Inc., was approved by the FDA in 2012 for the treatment of attention deficit hyperactivity disorder (ADHD) 10 PLIR 1293, 10/5/12.
There are no approved generic versions of the product, the agency said.
Pfizer Citizen Petition.
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