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FDA Alerts
Growth Hormone Disorders

FDA denies approval of somatrogon for growth hormone deficiency

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The U.S. Food and Drug Administration issued a Complete Response Letter for the Biologics License Application for the investigational once-weekly long-acting recombinant human growth hormone, somatrogon (Pfizer and OPKO Health), for the treatment of growth hormone deficiency (GHD) in children, according to a press release.

“We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world,” said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development in a statement. “We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families.”

Read the full press release here.

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