Lupin Launches Generic Drugs in US: USFDA Approval
Jun 03, 2024 17:11
Lupin has received USFDA approval to launch generic Doxycycline for Injection and Letermovir Tablets in the US market, targeting a combined annual market value of USD 362 million.
New Delhi, Jun 3 (PTI) Drug maker Lupin on Monday said it has launched a generic medication used to treat or prevent bacterial infections in the US market.
The company has launched Doxycycline for Injection USP (100 single-dose vial) in the US post approvals from the US Food and Drug Administration (USFDA), the Mumbai-based drug maker said in a statement.
The company's product is a generic equivalent of Pfizer Inc's Vibramycin for Injection which is indicated to reduce the development of drug-resistant bacteria.
As per the IQVIA MAT April 2024 data, Doxycycline for Injection USP had an estimated annual sale of USD 48 million in the US.
Lupin said it has also received tentative approval from the USFDA for its abbreviated new drug application for Letermovir Tablets, 240 mg and 480 mg.
The product is the generic equivalent of Merck Sharp & Dohme LLC's Prevymis tablets (240 mg and 480 mg).
Letermovir tablets are indicated to prevent disease caused by a virus called cytomegalovirus (CMV).
As per the IQVIA MAT April 2024 data, Letermovir tablets had an estimated annual sale of USD 314 million in the US.
Shares of the company on Monday ended 0.25 per cent at Rs 1,583.95 apiece on the BSE.
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