Alembic Pharma gets USFDA nod for generic drug

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat drug resistant bacterial infections, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets, the drug firm said in regulatory filing.

The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma International Pty Ltd (Mayne). Doxycycline Hyclate delayed-release tablets are indicated to reduce the development of drug resistant bacteria.

According to IQVIA data, Doxycycline Hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated market size of USD 10 million for twelve months ending September 2021.