PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.
Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.
"Sandoz is pleased to continue to expand patient access to this high-quality biopharmaceutical product, having received approvals for four new indications over the past two years," Sandoz president Don DeGolyer said. "The approval of Omnitrope for Turner syndrome will further allow us to meet the diverse needs of patients with growth-related conditions."
Omnitrope originally received approval from the FDA for pediatric growth-related disorders in 2006 under a new drug application, or NDA. Though Omnitrope is technically a follow-on biologic, no abbreviated approval pathway for follow-on biologics existed at the time, thus requiring its approval under the same pathway as the one used for branded pharmaceutical drugs.