Lupin gets USFDA approval for bacterial infection drug

The approval is to market a generic equivalent of bactrim oral suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Lupin has received the United States Food and Drug Administration (USFDA) approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL.

The approval is to market a generic equivalent of bactrim oral suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries.

Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, is indicated for the treatment and prevention of a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections), and certain type of pneumonia (pneumocystis-type).

According to the IQVIA MAT September 2020 data, Sulfamethoxazole and Trimethoprim Oral Suspension USP had estimated annual sales of approximately US $19 million in the US.


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