Biocon Gets USFDA Supplemental Approval for Yesintek Prefilled Autoinjectors
New Delhi: Biocon Limited's subsidiary in the United States has received supplemental U.S. Food and Drug Administration (FDA) approval for Yesintek 45 mg/0.5 ml single-dose prefilled autoinjector and Yesintek 90 mg/ml single-dose prefilled autoinjector.
Yesintek® was originally approved by the U.S. FDA on November 29, 2024.
"The Yesintek® single-dose prefilled autoinjector offers patients with another important treatment option. This new delivery format supports more tailored treatment approaches across different care settings and patient needs," the company said in a statement.
Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients 6 years of age and older, and moderate to severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating autoimmune conditions that affects tens of thousands of Americans.
This supplemental approval enhances Biocon’s comprehensive portfolio of immunology products in the United States and reaffirms the company’s commitment to improving access to affordable medicines for patients around the world.
