Zydus Lifesciences Ltd. has received tentative approval from the United States Food and Drug Administration for two of its products.

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The Ahmedabad-based drug major’s subsidiary Zydus Pharmaceuticals (USA) Inc. got tentative approval from the US drug regulator for Gabapentin Tablets as well as Canagliflozin and Metformin Hydrochloride tablets.

Gabapentin tablets 300 mg and 600 mg, prescribed to be taken once daily, are used for the management of Postherpetic Neuralgia (PHN).

Postherpetic Neuralgia is a condition in which patients experience lasting pain in the areas of their skin infected by shingles. Patients above the age of 50 are at a higher risk of getting PHN.

The formulation manufacturing facility at Moraiya in Gujarat will produce the drug.

Annual sales volume of Gabapentin tablets was $90 million in the US, according to the IQVIA data for the 12-month period ending in December 2022.

Zydus Lifesciences has also received tentative USFDA approval for Canagliflozin and Metformin Hydrochloride Tablets with 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg dosages.

Canagliflozin and metformin combination products are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or canagliflozin, or in patients already being treated with both canagliflozin and metformin.

The formulation manufacturing facility at Moraiya will produce these tablets as well.

Last week, Zydus Lifesciences received final approval from USFDA for Sirolimus tablets 1 mg and 2 mg, which is used to prevent rejection of kidney transplant by the body.

According to IQVIA data, for the 12-month period ending in December 2022, Canagliflozin and Metformin Hydrochloride Tablets had annual sales of $49.4 million in the United States.

The group now has 344 approvals and has filed over 440 ANDAs since the commencement of the filing process in the fiscal year 2004.

Shares of Zydus Lifesciences Ltd. ended 0.83 percent lower at Rs 466.75 on Monday.

(Edited by : Rukmani Krishna)