Pulin gets USFDA nod to market generic version of sulfamethoxazole, trimethoprim

Homegrown pharma major Pulin Ltd on Wednesday said it has received approval from the US health regulator to market its generic version of sulfamethoxazole and trimethoprim oral suspension used to treat bacterial infections. The approval by the United States Food and Drug Administration (USFDA) is for the strength of 200 mg/40 mg per 5 ml, a generic equivalent of Bactrim Oral Suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries, Inc, the company said in a regulatory filing

Sulfamethoxazole and trimethoprim oral suspension, 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)

Citing IQVIA MAT September 2020 data, the company said the sulfamethoxazole and trimethoprimoral suspension had estimated annual sales of approximately USD 19 million in the US.