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Gland Pharma gets USFDA approval for fertility treatment injection
KV Prasad Jun 13, 2022, 06:35 AM IST (Published)
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Summary
Cetrorelix Acetate for Injection helps prevent premature LH surges in women undergoing controlled ovarian stimulation by blocking the effects of GnRH, a hormone that regulates LH secretion and ovulation.
Gland Pharma on Monday, April 29, said that it has received approval from the United States Food and Drug Administration (USFDA) for Cetrorelix Acetate injection, which is used in women undergoing fertility treatment.
In a filing to the stock exchanges, Gland Pharma said that it is expecting to launch the drug in the strength of 0.25 mg/vial in the near-term through its marketing partner.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Cetrotide for Injection, 0.25 mg/vial, of EMD Serono Inc.
Cetrorelix Acetate for Injection helps prevent premature LH surges in women undergoing controlled ovarian stimulation by blocking the effects of GnRH, a hormone that regulates LH secretion and ovulation.
This addition to the company’s fertility product line highlights its dedication to producing advanced injectables to address patients’ needs, Glenmark Pharma said in the stock exchange filing.
Based on data from IQVIA, the product generated around $129 million in sales within the United States for the twelve-month period ended February 2024.
Earlier this month, Gland Pharma announced that it has obtained approval from the USFDA for Eribulin Mesylate injection, indicated for the treatment of metastatic breast cancer.
The product is anticipated to be the initial generic approval available in the market, and the company plans to introduce it soon in collaboration with its marketing partner.
The pharma major informed the bourses that it is co-developing several complex injectables, including the Eribulin Mesylate Injection, with Orbicular Pharmaceutical Technologies Pvt Ltd.
Gland Pharma shares were trading 0.78% lower at ₹1,715.5 apiece at 12:05 pm on the BSE.
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