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4th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 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 and maintain the effectiveness of Doxycycline Hyclate Delayed-Release Tablets and other antibacterial drugs, Doxycycline Hyclate Delayed-Release 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated market size of US$ 10 million for twelve months ending September 2021 according to IQVIA.
Alembic has received year to date (YTD) 16 approvals (12 final approvals and 4 tentative approvals) and a cumulative total of 155 ANDA approvals (135 final approvals and 20 tentative approvals) from USFDA.