More clinical trial sites should be included: CDSCO Panel tells Akum Pharma over Letrozole tablet
New Delhi: Noting more clinical trial sites should be included to have geographically distributed sites across India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major Akums Pharmaceutical to conduct the clinical trial of Letrozole Tablets 5mg.
This came after the firm presented the proposal for amendment of clinical trial protocol version no 2.1.
Letrozole is used to stimulate egg development and ovulation in female patients undergoing fertility treatment. Letrozole is an oral fertility medication. It can be used to induce ovulation in women who don’t ovulate or to produce multiple eggs in women who already ovulate on their own.
Letrozole is also used for treating breast cancer. It can also help prevent breast cancer from coming back. It is mainly prescribed for women who have been through menopause and have a type of cancer called "hormone-dependent" breast cancer.
Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have previously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer.
At the recent SEC meeting for reproductive and urology held on 21st June 2023, the expert panel reviewed the proposal presented by the drug major Akums Pharmaceuticals for the protocol amendment of clinical trial protocol version no 2.1. for Letrozole Tablets 5mg.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as per the protocol presented.
In continuation, the expert panel also recommended that more clinical trial sites should be included to have geographically distributed sites across India.
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