New Delhi: Strides Pharma Science said it has received approval from the US health regulator for its generic tetracycline hydrochloride capsules used for treatment of many bacterial infections.
The approval granted by the United States Food and Drug Administration (USFDA) to the company’s wholly-owned subsidiary, Strides Pharma Global, Singapore, is for multiple strengths of tetracycline hydrochloride capsules of 250 mg and 500 mg, the company said in a statement.
The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals (previously Heritage Pharmaceuticals), it added.
Citing IQVIA MAT data, the company said the US market for tetracycline hydrochloride capsules 250 mg and 500 mg is approximately USD 16 million.
The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma in the US market, it said.
Tetracycline hydrochloride capsule is an antibiotic used to treat many different bacterial infections of the skin, intestines, respiratory tract, urinary tract, genitals, lymph nodes, and other body systems, the company added.
In some cases, tetracycline hydrochloride capsule is used when penicillin or another antibiotic cannot be used to treat serious infections such as Anthrax, Listeria, Clostridium, Actinomyces, it said.
Strides Pharma Science said it has 123 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 84 ANDAs have been approved and 39 are pending approval.