USFDA gives nod for Levothyroxine Sodium For Injection

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad.

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USFDA Approval

Last Updated on November 30, 2022 by The Health Master

Ahmedabad: Zydus Lifesciences Limited‘s U.S. subsidiary, Zydus Pharmaceuticals (USA) Inc., has recently announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) to market levothyroxine sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial. Levothyroxine Sodium Injection is manufactured by Fresenius Kabi USA, LLC.

Myxedema coma is an extreme or decompensated form of hypothyroidism and, while uncommon, is potentially lethal. 

Primary symptoms of the disease are low body temperature and altered mental status.

The injection of levothyroxine sodium is used to treat myxedema coma.

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India.

According to IQVIA data (IQVIA MAT Sep 2022), the annual sales of levothyroxine sodium injection in the United States were USD 45.2 million.

The group now has 334 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad.

The company is primarily engaged in the manufacture of generic drugs.

Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.

Zydus‘ global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa.

It is also present in a big way in 25 other emerging markets worldwide.

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