Eugia Pharma gets USFDA nod for generic drug: Aurobindo Pharma

Aurobindo Pharma on Friday said its joint venture firm Eugia Pharma Specialities has received approval from the US health regulator to market Methotrexate tablets, used to treat various types of cancer, in the American market.

Eugia Pharma, in which the company holds a stake, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Methotrexate tablets (2.5 mg), Aurobindo Pharma said in a regulatory filing.

The company's product is the generic version of Dava Pharmaceuticals' Rheumatrex tablets, it added.

"The product will be launched in March 2020," the Hyderabad-based firm said.

As per IQVIA data, the product had an estimated market size of USD 98 million (about Rs 695 crore) for the twelve months ended December 2019.

Methotrexate tablets are indicated in the treatment of gestational choriocarcinoma. They are also used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer.

The drug is also used in the treatment of psoriasis and rheumatoid arthritis.

"This is the ninth abbreviated new drug application (ANDA) to be approved out of Eugia's formulation facility in Hyderabad," Aurobindo Pharma said.

The drug major now has a total of 420 ANDA approvals from the USFDA.

Shares of Aurobindo Pharma on Friday ended 0.22 per cent higher at Rs 481.35 apiece on the BSE.