Zydus Cadila gets US FDA nod to market anti-obesity drug

Zydus Cadila has received approval from the US health regulator to market Phentermine Hydrochloride orally disintegrating tablets used for the treatment of obesity in the American market.

The company has received final approval from the United States Food and Drug Administration (US FDA) to market Phentermine Hydrochloride orally disintegrating tablets in strengths of 15 mg, 30 mg, and 37.5 mg, Zydus Cadila said in a statement.

The drug will be produced at the group’s formulations manufacturing facility at Moraiya in Ahmedabad, it added.

The product is used together with diet and exercise to treat obesity (overweight) in people with risk factors such as high blood pressure, high cholesterol or diabetes, Zydus Cadila said.

The group now has more than 120 approvals and so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process.