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.

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RTTNews | Jan 4, 2021 07:02AM EST

07:02 Monday, January 4, 2021 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3157281/pfizer-opko-fda-to-review-bla-for-somatrogon-to-treat-patients-with-growth-hormone-deficiency.aspx)

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