Zydus gets regulatory nod to market Lipaglyn in Mexico
New Delhi: Drug firm Zydus said it has received approval from the Mexican regulatory authority to market Lipaglyn (Saroglitazar Magnesium) used for the treatment of dyslipidemia in patients with diabetes.
The company has been granted marketing approval from the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) to commercialize Lipaglyn in Mexico, Zydus said in a statement.
"Saroglitazar is an important scientific and medical breakthrough in our effort to develop medicines for patients suffering from hypertriglyceridemia and diabetic dyslipidemia," Zydus Group Chairman Pankaj Patel said.
This approval of Saroglitazar in Mexico is a major milestone for the company, he added.
"Lipaglyn is used for the treatment of dyslipidemia in patients with diabetes mellitus type 2 and hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins," Zydus said.
Lipaglyn, a prescription drug, was first launched in India during September 2013, Zydus said.
"Over the last several years, more than 500,000 patients have been treated with Lipaglyn in India...," it added.