Lupin receives tentative FDA OK for generic Prevymis, launches generic Vibramycin
Lupin has received the Food and Drug Administration’s tentative approval for a new generic, and the company has launched a new generic product.
Lupin received tentative approval from the FDA for letermovir tablets, 240 mg and 480 mg, which is a generic of Merck Sharp & Dohme’s Prevymis. 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 infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.
[Read more: Lupin receives FDA OK for generic Banzel]
Letermovir tablets had a market value of roughly $314 million, per IQVIA April 2024 data
Lupin is introducing doxycycline for injection, 100 mg/Vial (single-dose vial), which is a generic of Pfizer’s Vibramycin. It is indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs. Doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria, the company said.
[Read more: Lupin receives FDA nod for 3 generics]
Doxycycline for injection had a market value of roughly $48 million, per IQVIA April 2024 data.