Sanofi's Thyrotropin Alfa Label Update: CDSCO Panel Recommends New Prescription Warning, Limits Sale to Specialists Only

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has approved an amendment in the warning statement of Thyrotropin Alfa lyophilized powder for solution for injection 0.9 mg/mL, manufactured by Sanofi Healthcare India, after detailed deliberations.

The firm had presented a proposal seeking revision of the existing warning statement of the drug from “To be sold by retail on the prescription of a registered Oncologist only” to “To be prescribed by Oncologist, Nuclear Medicine Physicians, Endocrinologists and ENT/Endocrine surgeons”.

The proposal was examined by the committee in detail, taking into account the therapeutic use of the drug and the specialties involved in its administration. Following deliberations, the SEC recommended a modified approval, partially accepting the proposal.

Thyrotropin alfa is a recombinant form of thyroid-stimulating hormone used in diagnostic testing for thyroid cancer and alongside radioactive agents to destroy thyroid tissue.

Thyrotropin Alfa binds to the thyrotropin receptors found on any residual thyroid cells or tissues. This stimulates radioactive iodine uptake for better radiodiagnostic imaging.

After detailed deliberation, the committee recommended approval for the following warning statement:

“To be sold by retail on the prescription of Oncologist, Nuclear Medicine Physician and Endocrinologist Only”