Claris gets USFDA nod for hypertension drug

The company now has 10 ANDAs approved in its name across six molecules; a total filing of 32 ANDAs across 21 molecules

Ahmedabad-based injectables player Claris Lifesciences has received the US drug regulator's nod for its abbreviated new drug application (ANDA) for Metoprolol Tartrate injections.

The drug is used to treat angina (chest pain) and hypertension.

The company has received nod to market the drug in strengths of 1 mg/ ml in 5ml glass vials, it said in a statement here.

Metoprolol Tartrate injections are also used to treat or prevent heart attack.

According to the American Heart Association, an estimated 1.4 million people annually will suffer a heart attack.

Also, IMS data indicates in 2009 sales of Metoprolol was around $13 million (Rs 69.8  crore ).

In US, Claris markets its products through its wholly owned subsidiary Claris Lifesciences Inc.

The company now has 10 ANDAs approved in its name across six molecules, and has a total filing of 32 ANDAs across 21 molecules.

Claris is one of the largest sterile injectables companies in India, which has presence across 98 countries.

It manufactures and markets products across various therapeutic segments including anesthesia, plasma volume expanders, blood products, parenteral and enteral nutrition, infusion therapy, anti-infectives and renal care.