The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing.
').insertAfter(".article-content__img");$(".article-content__img div").find('div').remove();
Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection.
The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing.
The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Exclusive Stories, Curated Newsletters, 26 years of Archives, E-paper, and more!
First Published: Tue, January 17 2023. 00:14 IST
There is something quietly symbolic about JPMorgan Chase choosing Berlin as its gateway into continental Europe. In a fo... Read more
There is a moment in every bull run when the narrative starts to fray. Not with a crash, not with a scandal, but with so... Read more
Coutts steps into private marketsCoutts, the private bank best known for serving Britain’s wealthiest families and the... Read more
How Crypto Moved from the Wild West to the Mainstream Financial SystemA long-form analysis of Bitcoin's journey from fri... Read more
ACB Securities: Building Scale, Trust and Innovation in Vietnam’s Capital MarketsACB Securities (ACBS) is emerging as ... Read more
For most of the past year, global markets behaved as though geopolitical risk had largely disappeared. Inflation was eas... Read more
