Lupin gets US FDA approval for Sulfamethoxazole and Trimethoprim

Lupin has received the United States Food and Drug Administration 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.