Is zomacton fda approved?

Is Zomacton FDA-Approved?

Zomacton, a somatropin recombinant human growth hormone, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Pediatric Growth Hormone Deficiency in children and Growth Hormone Deficiency in adults [1].

According to the FDA, Zomacton was first approved in 2003 for the treatment of Pediatric Growth Hormone Deficiency in children aged 2 years and above and Growth Hormone Deficiency in adults who have either hypothalamic or pituitary function impairment [2].

Approved Indications and Age Groups

Zomacton is approved for the following indications and age groups:

1. Pediatric Growth Hormone Deficiency in children: approved for children aged 2 years and above
2. Growth Hormone Deficiency in adults: approved for adults with hypothalamic or pituitary function impairment

Manufacturing and Distribution

Zomacton is manufactured by Pfizer, a pharmaceutical company that markets and distributes the product globally [3]. As a prescription medication, it can only be obtained through a healthcare provider.

Exclusivity and Patent Information

According to DrugPatentWatch.com, the original patent for Zomacton expired in 2018, and the active patent has expired. However, the product may still be under trade dress protection [4].

Conclusion

In summary, Zomacton, an FDA-approved somatropin recombinant human growth hormone, is used to treat Pediatric Growth Hormone Deficiency in children and Growth Hormone Deficiency in adults.

References:
[1] U.S. Food & Drug Administration. (2003). Omnitrope (somatropin for injection) for injection, for intramuscular use.
[2] Pfizer. (n.d.). Zomacton (Somatropin for injection).
[3] Pfizer. (n.d.). About Pfizer.
[4] DrugPatentWatch. (n.d.). Zomacton patent expiry.