Combination Products See FDA Issue CRLs

Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products.

Supernus Pharmaceuticals said that the FDA’s CRL mentions two areas in the company’s NDA for SPN-830 (an apomorphine infusion device for treatment of motor fluctuations in Parkinson’s disease) that require additional review or information: one relating to the drug’s product quality and one relating to the infusion device’s master file, which is proprietary to the device manufacturer.

IntelGenx announced that its co-developer, Chemo Research, has received a CRL from the FDA on its resubmitted ANDA for buprenorphine buccal film. An earlier CRL was received on the buccal film in April 2023 and IntelGenx responded to that CRL in September 2023.

To read the whole story, click here.

Related Topics