US FDA Approved Zydus Lifesciences’ Generic Drug to Treat Myxedema Coma


As per a financial exchange documenting, Zydus Lifesciences Restricted, previously Cadila Medical services Restricted, has gotten endorsement from the US wellbeing controller to showcase a conventional item.

In a BSE statement, the company said that Zydus has received final approval from the United States Food and Drug Administration (USFDA) for levothyroxine sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial.

Injections of levothyroxine sodium are used to treat myxedema coma. At Zydus’ injectable manufacturing facility in Jarod, India, near Vadodara, the drug will be made.

Doxepin hydrochloride capsules USP in strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg have also been approved by the company simultaneously.

Psychoneurotic patients with depression and/or anxiety, depression and/or anxiety associated with alcoholism and organic disease, and psychotic depressive disorders with associated anxiety, such as involutional depression and manic-depressive disorders, should take a capsule of doxepin hydrochloride. According to the company, the drug will be produced at the formulation manufacturing facility of the group in Moraiya, Gujarat, India.

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After these two endorsements, Zydus has a sum of 355 endorsements and has so far recorded north of 440 ANDAs (starting around 31 December 2022). In FY 2003-2004, the company began the filing process.