Lupin gets USFDA’s approval for Sulfamethoxazole and Trimethoprim Oral Suspension

06 Jan 2021 Evaluate

Lupin has received approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Bactrim Oral Suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries, Inc.

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). Sulfamethoxazole and Trimethoprim Oral Suspension USP (RLD: Bactrim) had estimated annual sales of approximately $19 million in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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