Regulatory Zydus Lifesciences Gets FDA Green Light For Thyroid Hormone...

Zydus Lifesciences Gets FDA Green Light For Thyroid Hormone Deficiency Drug


The United States Food and Drug Administration (USFDA) has granted Zydus Lifesciences permission to market Levothyroxine Sodium injection, a medication used to treat a lack of thyroid hormone. According to a regulatory filing by the pharmaceutical company, the company’s division based in the U.S. has been granted provisional approval to sell the medication by the FDA.

Zydus Lifesciences Limited is an Indian pharmaceutical company with its headquarters in Ahmedabad, India. The main focus of the company is the production of generic pharmaceuticals. There are Zydus Group factories and labs in five different Indian states: Gujarat, Sikkim, Maharashtra, Goa, and Himachal Pradesh, as well as outside India in the U.S. and Brazil.

This nod comes just a few weeks after the FDA gave clearance to the company’s generic hypertension drug, Bisoprolol Fumarate, making it a good month for the company.

“Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. 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,” Zydus Lifesciences said in a regulatory filing.

The drug will be produced at the injectable manufacturing facility that the company has in Jarod, which is located close to Vadodara in India.

Data from IQVIA shows that annual sales of levothyroxine sodium injection in the U.S. amounted to $45.2 million. Over 431 ANDAs have been submitted by the company since the filing process began in FY 2003-04, and 334 have been approved.

Levothyroxine is a thyroid hormone supplement for those whose bodies do not produce enough of this hormone naturally. Weight gain, cold intolerance, fatigue, and dry skin are just some of the symptoms of low thyroid hormone that can be alleviated with levothyroxine. In addition, it’s used as a treatment for myxedema coma, a life-threatening condition characterized by severe hypothyroidism. It could take this medication a few weeks to begin showing any significant improvement in your condition.

As myxedema coma is so uncommon, there have been no well-controlled clinical trials conducted to determine the best treatment approach or dosage of thyroid hormone for this condition. Levothyroxine (T4) is favored by some doctors, while liothyronine (T3) and a combination of the two is favored by others in the medical community. Therapy with both T4 and T3 is encouraged by the American Thyroid Association. Experts stress that thyroid hormone levels should be checked once every two to three days. 

Within a week of starting intravenous levothyroxine treatment, patients with severe hypothyroidism typically show improvements in cardiopulmonary, renal, and metabolic parameters. A similar amount of time may be required for normalization of serum T4 and T3 levels, while serum TSH levels may improve more slowly but still eventually. So, the goals of treatment for myxedema coma should be better mental status, lung and heart function.

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