Lupin receives tentative approval from U.S. FDA for Letermovir tablets

The generic equivalent of Prevymis, will be manufactured at Lupin’s Nagpur facility in India

Lupin has announced that it has received a tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Letermovir Tablets, 240 mg and 480 mg, to market a generic equivalent of Prevymis Tablets, 240 mg and 480 mg, of Merck Sharp & Dohme. This product will be manufactured at Lupin’s Nagpur facility in India.

Letermovir Tablets, 240 mg and 480 mg are indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.