Alembic Pharmaceuticals receives US FDA approval for Doxycycline Hyclate delayed-release tablets

Alembic Pharmaceuticals today received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Doryx tablets, 75 mg, 100 mg, 150 mg and 200 mg, of Mayne Pharma International, Alembic Pharma notified via a statement.

Doxycycline Hyclate delayed-release tablets are indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate delayed-release tablets and other antibacterial drugs. These tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying anti-bacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy, the statement said.

Further, according to the statement, Doxycycline Hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated market size of $10 million for twelve months ending September 2021 as per IQVIA.