CDSCO Panel rejects AstraZeneca's proposal to amend warning statement of Goserelin Acetate Depot Injection
New Delhi: Rejecting the drug major AstraZeneca's proposal to amend the warning statement for Goserelin Acetate Depot Injection 10.8mg (Zoladex) under condition 04 of the marketing permission, the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised the firm to submit the revised application with the request of inclusion of urologist in the warning statement.
This came after the drug major AstraZeneca presented their proposal for expanding the present warning statement for Goserelin Acetate Depot Injection 10.8mg (Zoladex) under condition 04 of the marketing permission i.e. “To be sold on the prescription of an oncologist only” to “To be sold on the prescription of an oncologist/specialist only”.
Goserelin is a synthetic analog of luteinizing hormone-releasing hormone (LHRH) used to treat breast cancer and prostate cancer by reducing the secretion of gonadotropins from the pituitary. Goserelin is a synthetic decapeptide analog of LHRH. Goserelin acts as a potent inhibitor of pituitary gonadotropin secretion when administered in a biodegradable formulation. The result is sustained suppression of LH and serum testosterone levels.
Goserelin acetate depot injection 10.8 mg is marketed by AstraZeneca under the brand name Zoladex and is used to treat endometriosis, uterine fibroids, breast cancer, prostate cancer, and female infertility.
At the recent SEC meeting for Oncology and Hematology held on 25th July 203, the expert panel reviewed the proposal presented by drug major AstraZeneca for expanding the present warning statement under Condition 04 of the marketing permission i.e. “To be sold on the prescription of an oncologist only” to “To be sold on the prescription of an oncologist/specialist only”.
After detailed deliberation, the committee did not recommend expanding the present warning statement in its present form.
In accordance with the above, the committee recommended that the firm should submit the revised application with the request for the inclusion of a urologist instead of a specialist for further consideration.
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