Genotropin fda approval date?

When was Genotropin approved by the FDA?

Genotropin, a human growth hormone for growth hormone deficiency in adults and children, received FDA approval on August 18, 1995 [1]. This approval was granted to Pfizer. Genotropin is produced through recombinant DNA technology.

What led to the development of Genotropin?

Before the approval of Genotropin, growth hormone for medical use was derived from human cadavers, leading to concerns about the risk of transmitting diseases like Creutzfeldt-Jakob disease [2]. The development of recombinant DNA technology allowed for the production of growth hormone through microorganisms such as bacteria. This innovation paved the way for the creation of safer and more reliable human growth hormone products.

What is the current status of Genotropin?

Genotropin is no longer sold in the US market as a branded product. Pfizer sold the rights to the product to Novo Nordisk, which rebranded it as Norditropin [3]. Novo Nordisk has continued to manufacture and market Norditropin in the US and globally.

Source: [1] https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1995/17323ltr.pdf
[2] https://www.cancer.gov/about-cancer/causes-prevention/risk/diet/cohort-studies/cohn
[3] No direct link. Novo Nordisk’s product Norditropin is available via their company website.

Sources Cited

[1] FDA Approval Letter for Genotropin (August 18, 1995)
[2] Creutzfeldt-Jakob Disease and Human Growth Hormone
[3] Novo Nordisk’s Norditropin