CDSCO Panel Backs Label Change Allowing Endocrinologists, Rheumatologists to Prescribe Amgen's Romosozumab

Romosozumab Injection 90 mg/mL is approved in India for the treatment of osteoporosis in postmenopausal women at high risk of fracture. The firm placed a proposal before the committee seeking modification of the existing warning statement mentioned on the approved label of the drug.

As per the existing approval, the warning statement restricts the retail sale of the drug to prescriptions issued by Registered Orthopaedics only. The company proposed revising this statement to read: “To be sold by retail on the prescription of Registered Orthopaedicians, Endocrinologists and Rheumatologists experienced in treating the disease(s) as per the approved label.”

During the meeting, the proposal was examined in detail by the committee. The SEC reviewed the approved indication of Romosozumab Injection and deliberated on the clinical management of osteoporosis. The committee noted that osteoporosis is a metabolic bone disorder that is routinely managed by multiple specialties, including endocrinologists and rheumatologists, particularly in patients with hormonal, metabolic, or systemic risk factors.

After detailed deliberation, the SEC agreed with the firm’s proposal and recommended approval of the addition of Registered Endocrinologists and Rheumatologists to the warning statement of the drug product. The committee clarified that the expanded prescribing authority applies strictly to the approved indication of osteoporosis treatment and that prescriptions should be issued only by specialists experienced in managing the disease, in line with the approved product label.

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