Claris Lifesciences has received the Abbreviated New Drug Application (ANDA) approval for Furosemide Injection in the United States of America (US). This product will be sold in 10 mg/ml formulation packed in 20mg/2ml, 40mg/4ml and 100mg/10ml single dose vials having approximately market size of $22 million. This brings the company’s total tally of approved and marketable ANDAs to 13 with estimated addressable market size of $204.33 million.
Furosemide is used to treat edema (fluid retention) that occurs with congestive heart failure and disorders of the liver, kidney, and lung. It is also used to control mild to moderate high blood pressure. It may be used in combination with other medications to treat more severe high blood pressure.
The product has been facing supply issues in USA during the past year on various occasions and has also featured in the USFDA shortage list since June 2012. Presently there are only 4 other companies who have an approved ANDA for this product. Claris is the only company out of the emerging markets to have received the ANDA approval for the US.
Furosemide is used to treat edema (fluid retention) that occurs with congestive heart failure and disorders of the liver, kidney, and lung. It is also used to control mild to moderate high blood pressure. It may be used in combination with other medications to treat more severe high blood pressure.
The product has been facing supply issues in USA during the past year on various occasions and has also featured in the USFDA shortage list since June 2012. Presently there are only 4 other companies who have an approved ANDA for this product. Claris is the only company out of the emerging markets to have received the ANDA approval for the US.
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