Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market doxycycline injection used for treatment of bacterial infections in the American market. The company has “received the final approval from the United States Food and Drug Administration (USFDA) to market doxycycline for injection USP, 100 mg per vial and 200 mg per vial (single-dose vial),” Zydus Cadila said in a statement.
The product will be manufactured at the group’s formulations manufacturing facility in Moraiya in Ahmedabad, it added. The drug, an anti-biotic, is “indicated to treat or prevent a variety of infectious disorders that are proved or strongly suspected to be caused by susceptible bacteria”.
“The group now has more than 160 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs)” since the commencement of the filing process by the company.