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Pfizer, OPKO: FDA To Review BLA For Somatrogon To Treat Patients With Growth Hormone Deficiency

Pfizer Inc. (PFE) and OPKO Health Inc. (OPK) announced FDA has accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone for the treatment of pediatric patients with growth hormone deficiency. The target PDUFA action date for decision by the FDA is in October 2021.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon. OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

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