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Claris gets nod for Ondensetron injection in US

Posted on Feb 25, 03:14PM | IBNS

New Delhi, Feb 25 : Claris Lifesciences Limited (Claris), a leading sterile injectables pharmaceutical company, announced on Monday that it has received two Abbreviated New Drug Application (ANDA) approvals for Ondensetron Injection in the United States of America (US). Ondensetron Injection is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and for prevention of postoperative nausea and/or vomiting.

The company plans to launch Ondensetron in two variants of 2 mg/mI in 2 ml single dosage vials and 20 ml multi dosage vials.

The total addressable market size of the product is estimated at USD 49 million in the US.

Claris had recently received the long awaited US-FDA approval for its manufacturing facility.

The company now has nine ANDAs approved in its name across four molecules.

It has a total filing of 30 ANDAs across 20 products.