Pfizer and Opko Health announce the extension of the PDUFA date for review of somatrogon.
The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer’s submission of additional data to the original BLA.
In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.
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