Categories: Accreditation

Lupin gets USFDA nod to market HIV drug in US market

                       

Lupin shares gains more than 1% on US health regulator’s nod for generic Trizivir tablets

New Delhi December 11, 2013:  

Drug major Lupin Ltd on Tuesday said it has received US health regulator’s approval to market generic version of ViiV Healthcare Ltd’s Trizivir tablets, used in the treatment of HIV-1 infection, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) for its Abacavir Sulfate Lamivudine, and Zidovudine tablets, Lupin said in a statement.
The company’s product is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection, it added.
“Lupin was the first applicant to file an abbreviated new drug application (ANDA) for Trizivir tablets and as such will be entitled to 180 days of marketing exclusivity,” the company said.
According to IMS MAT September 2013 sales data, Trizivir tablets has US sales of around $111.6 million.
Lupin’s cumulative ANDA filings with the USFDA as of 30 October stands at 183 and the Mumbai-headquartered firm has received 93 approvals to date.
During the current year, the company has so far received 17 approvals from USFDA. It has also launched 13 products in the US market in the current year so far.
“Lupin is the market leader in 26 products in the US generic market and is amongst the top three by market share in 40 products out of the overall 57 products in the market,” it the company said.
Shares of Lupin were trading at Rs.863.70 a piece on the BSE in afternoon trade, up 1.28% from its previous close.
The Pharma Times News Bureau

Recent Posts

8 Ways Insomnia Affects Skin Health & How To Avoid It

By Dr. Priyanka Kuri, Consultant - Dermatology, Aster Whitefield Hospital, Bengaluru Insomnia, the persistent inability…

17 hours ago

Breaking New Ground in Migraine Care: A Landmark Session on Diagnosis and Treatment

Illuminating Latest Advances in Migraine Diagnosis and Treatment New Delhi, December 21, 2024: In a…

18 hours ago

Healthcare Startups to Watch Out for in 2025

New Delhi, December 20, 2024: The healthcare sector is undergoing a transformation fueled by technological…

2 days ago

DKMS’s First Global Impact Report of 2023 Serves as New Ray of Hope for Blood Cancer Patients Worldwide

National, December 20, 2024: DKMS just published its first Global Impact Report that outlines the organization's…

2 days ago

Sterling Biotech to start world’s first precision fermentation-based dairy protein factory in Gujarat

Ahmedabad, December 19, 2024: Sterling Biotech Limited, a joint venture between Perfect Day and Zydus, has…

3 days ago

Pioneers in Senior Care, Antara, Partners with Leading Diagnostics Player Dr. Lal PathLabs to Strengthen its Geriatric Care Services

New Delhi, December 19, 2024: Antara Senior Care, an integrated eco-system provider for lifestyle and…

3 days ago