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Somatrogon FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 12, 2021.

FDA Approved: No
Generic name: somatrogon
Company: Pfizer Inc.
Treatment for: Pediatric Growth Hormone Deficiency

Somatrogon is an investigational, long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

Development Timeline for somatrogon

Jan 21, 2022Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency
Sep 24, 2021Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency
Jan  4, 2021US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
Oct 21, 2019OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

Further information

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