FDA Clears Omnitrope; Product Is Not The Process, But Nor Is It A Pathway
Sandoz' approval for the first follow-on version of a human growth hormone product relies on data from a Phase III clinical program that studied 89 pediatric patients
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Sandoz, Hospira execs say U.S. payers and consumers will ‘not be disappointed’ in cost savings from products approved under the 351(k) pathway, but warn that price alone may not tell whole story.
Generic firm is counting on Global Biologics Head Patrick Vink’s experience as Sandoz biopharma head to lead the firm into the follow-on biologics marketplace.
Sandoz sued FDA in its effort to win approval of Omnitrope (somatropin [rDNA origin]). Now the company is using more mundane regulatory procedures as it works to expand sales of its follow-on human growth hormone