Zydus Life gets final US FDA nod for depression and anxiety treatment capsules

On March 21, Zydus Lifesciences had received final approval from the US FDA for Tofacitinib tablets, 5 mg, and 10 mg, respectively, for treatment of certain types of arthritis. Prior to this, the pharma company received final approval from USFDA for Erythromycin tablets USP, 250 mg and 500 mg, which is used to treat a wide variety of bacterial infections.

The company has also received final approval for Lubiprostone Capsules, 8 mcg and 24 mcg from US FDA.

Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation).

The company, in an exchange filing, has said, “Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereinafter referred to as ‘Zydus’) has received final approval for Lubiprostone Capsules, 8 mcg and 24 mcg (USRLD: Amitiza Capsules) from the USFDA.”

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Lubiprostone Capsules, 8 mcg and 24 mcg had annual sales of $196.5 million in the United States (IQVIA MAT, January 2023).

The group now has 354 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY2003-04.

The shares of Zydus Life till 11:10 am were trading 0.1 percent higher at Rs 482.8 per share.