Alembic Pharmaceuticals gets FDA approval for Doryx Tablets generic

Alembic Pharmaceuticals has bagged final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets USP in the strengths of 75 mg, 100 mg, 150 mg, and 200 mg.

Doxycycline Hyclate Delayed-Release Tablets USP is Alembic Pharmaceuticals’ generic version of Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, owned by Mayne Pharma International.

According to Alembic Pharmaceuticals, Doxycycline Hyclate Delayed-Release Tablets has approval for the reduction of the development of drug-resistant bacteria and sustaining the effectiveness of Doxycycline Hyclate Delayed-Release Tablets as well as other antibacterial drugs.

Doxycycline Hyclate Delayed-Release Tablets is to be used only for the treatment or prevention of infections that are proven or suspected strongly to be resulting from susceptible bacteria.

Alembic Pharmaceuticals said that when culture and susceptibility details are available, they should be taken into account for selecting or altering antibacterial therapy. When such data is not available, local epidemiology and susceptibility patterns could contribute to the empiric selection of therapy, said the Indian pharma company.

As per according to IQVIA, there is an estimated market size of $10 million for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg for 12 months ending September 2021.