CDSCO Panel rejects AstraZeneca's proposal to amend warning statement of Goserelin Acetate Depot Injection

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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