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Zydus Receives USFDA Approval to Manufacture Its Generic Prostate Cancer Drug | Company news

2 minutes read Last updated: September 28, 2024 | 6:36 p.m IS

Zydus Lifesciences said Saturday that it received approval from the U.S. Food and Drug Administration to produce a generic drug to treat prostate cancer.

The company has received approval from the US Food and Drug Administration (USFDA) to manufacture enzalutamide capsules (40 mg), it said in a regulatory filing.

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Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

The drug will be manufactured at the group's manufacturing facility in Moraiya, Ahmedabad, Zydus said.

According to IQVIA MAT data as of July 2024, enzalutamide capsules (40 mg) generated annual sales of $869.4 million in the United States.

The group now has over 400 approvals and has submitted over 465 abbreviated new drug applications (ANDAs) since the application process began in the 2003/2004 financial year.

Biocon gets 4 observations from USFDA for API plant in Bengaluru

Biocon said on Saturday that the US health regulator made four observations after inspecting its Bengaluru-based API (active pharmaceutical ingredients) plant.

The US Food and Drug Administration (USFDA) conducted a surveillance inspection of API's facility (Site 2) in Bengaluru from September 23 to 27, 2024, the company said in a regulatory filing.

“At the end of the inspection, four comments were made, which the company will address within the specified timeframe,” it said.

The company does not expect any impact on business, Biocon said.

(Only the headline and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First published: September 28, 2024 | 6:36 p.m IS

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