Drug Approval | July 24, 2023
Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
This product would be manufactured at Lupin's Nagpur facility in India
This product would be manufactured at Lupin's Nagpur facility in India
Luforbec® 100/6 pMDI aims to provide comprehensive support to patients and healthcare professionals
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
Lupin has received US$ 25 million from AbbVie for initiation of Phase 1 clinical studies successfully
This product will be manufactured at Lupin's Pithampur facility in India
The partnership aims to prioritize the diagnosis and treatment of these diseases while working to reducing their long-term prevalence
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
The inspection closed with the facility receiving an inspection classification of NAI
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