FDA Approves Generic Sirolimus Tablets, for Immunosuppression

Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection.

Officials with the FDA have approved Glenmark Pharmaceuticals’ Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, according to the company.1 The drug product is the generic version of Pfizer and Wyeth Pharmaceuticals’ Rapamune Tablets, 0.5 mg, 1 mg and 2 mg.1,2

Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged 13 years and older receiving renal transplants, but is not recommended for patients with lung or liver transplants. Sirolimus tablets are administered once daily.2

Sirolimus was initially approved by the FDA in 1999.2 According to IQVIA sales data obtained by Glenmark for the 12 month period ending August 2020, the market for sirolimus tablets, 0.5 mg, 1 mg and 2 mg achieved annual sales of approximately $119.7 million.1

REFERENCES

  • Glenmark Pharmaceuticals receives ANDA approval for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg [news release]. Mumbai, India; October 19, 2020: Glenmark. Accessed October 19, 2020. https://www.glenmarkpharma.com/sites/default/files/Glenmark-Pharmaceuticals-receives-ANDA-approval-for-Sirolimus-tablets.pdf
  • Rapamune [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals; January 2020. Accessed October 19, 2020. http://labeling.pfizer.com/showlabeling.aspx?id=139