Zydus Lifesciences US arm wins USFDA nod for Levothyroxine Sodium for Injection to treat myxedema coma

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

Published On 2022-11-28 06:02 GMT   |   Update On 2022-11-28 06:04 GMT

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 manufactured by Fresenius Kabi...

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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 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.  

Levothyroxine Sodium injection is indicated for the treatment of myxedema coma. 

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

Levothyroxine Sodium injection had annual sales of USD 45.2 mn in the United States, according to IQVIA data (IQVIA MAT Sep 2022). 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.  

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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.  

Read also: Zydus Lifesciences Chief Pankaj R Patel appointed as new Chairperson of IIM Ahmedabad Board of Governors

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