Zydus Lifesciences gets USFDA nod for Leuprolide Acetate injection

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of Leuprolide Acetate injection used in palliative treatment of advanced prostatic cancer.

The approval by the US Food and Drug Administration (USFDA) is for Leuprolide Acetate injection of strengths 14 mg/2.8 ml (1 mg/0.2 mL) multiple-dose vial (reference listed drug Lupron Injection, 1 mg/0.2 mL), Zydus Lifesciences said in a regulatory filing.

The Leuprolide Acetate injections will be manufactured at the company’s oncology injectable manufacturing facility at SEZ1, Ahmedabad, it added.

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. It had annual sales of USD 69 million in the US, the company said citing IQVIA MAT September 2025 data.

Related Posts

Centre flags serious lapses in state’s blood banks

Jaipur: Union health ministry has flagged “serious lapses” in Rajasthan’s blood bank management after inspections found shortcomings including inadequate record-keeping, lack of proper ELISA testing, and failures to communicate HIV-positive…

Sun Pharma Launches UNLOXCYT for Advanced Skin Cancer in US

New Delhi: Sun Pharmaceutical Industries Limited has announced that UNLOXCYT (cosibelimab-ipdl) is now available in the United States for prescription by healthcare professionals for the treatment of adults with metastatic…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Centre flags serious lapses in state’s blood banks

Centre flags serious lapses in state’s blood banks

Sun Pharma Launches UNLOXCYT for Advanced Skin Cancer in US

Sun Pharma Launches UNLOXCYT for Advanced Skin Cancer in US

Unlicensed medical device stock worth Rs. 4.47 lakh seized in Gurugram raid

Unlicensed medical device stock worth Rs. 4.47 lakh seized in Gurugram raid

Controlled substances charge: Court summons Ramdev, Amazon founder

Controlled substances charge: Court summons Ramdev, Amazon founder

Allahabad HC refuses to quash case against pharma company linked to cough syrup deaths in Uzbekistan

Allahabad HC refuses to quash case against pharma company linked to cough syrup deaths in Uzbekistan

IPC registers 44 small-scale medtech firms under ADRMS

IPC registers 44 small-scale medtech firms under ADRMS