Drug Approval | April 18, 2022
Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
This product will be manufactured at Lupin’s Nagpur facility in India
This product will be manufactured at Lupin’s Nagpur facility in India
The product will be manufactured at Lupin’s facility in Goa, India
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
The product will be manufactured at Lupin’s facility in Goa, India
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis
Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA
The product will be manufactured at Lupin’s facility in Goa, India
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