Drug Approval | May 06, 2022
Zydus receives tentative approval from USFDA for Selexipag tablets
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
The tablets are available in 100 mg strength in bottle count sizes of 60
This product will be manufactured at Lupin’s Nagpur facility in India
The product will be manufactured at Lupin’s facility in Goa, India
In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP
According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The company plans to launch the product immediately
Ritonavir oral tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of the approved oral antiviral drug Paxlovid (Nirmatrelvir 300 mg tablet + ritonavir 100 mg tablet co-administration package)
It is only the second generic application approved by the USFDA
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