Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxycycline for Injection USP, 100 mg/Vial (Single-Dose Vial), to market a generic equivalent of Vibramycin for Injection, 100 mg/Vial, of Pfizer Inc.
The product will be manufactured at Lupin’s Nagpur facility in India.
Doxycycline for Injection USP is indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs. Doxycycline for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline for Injection USP (RLD Vibramycin) had estimated annual sales of USD 47 million in the U.S. (IQVIA MAT January 2024).
