Claris Lifesciences, an Ahmedabad based sterile injectables pharmaceutical company, has received two Abbreviated New Drug Application (ANDA) approvals for Ondensetron injection in the United States of America (US).
Ondansetron 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/ml in 2 ml single dosage vials and 20 ml multi dosage vials.
The total addressable market size of the product is estimated at US$ 49 million in the US. Claris had recently received the long awaited US FDA approval for its manufacturing facility. Company now has nine ANDAs approved in its name across four molecules. The Company has a total filing of 30 ANDAs across 20 products.