Drug Approval | 06 May 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 approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA
With the introduction of this device, Alkem is entering the core inhalation therapeutics and envisaging that the drug will reach the lungs effectively in each inhalation with added patient awareness and adherence programmes
Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients
This action makes Veklury the first approved Covid-19 treatment for children less than 12 years of age
Trelegy is delivered via the innovative Ellipta inhaler that provides accurate dosing through its consistent dose delivery mechanism and is associated with less inhaler teaching time compared to other commonly used inhalers
The approval comes soon after Corbevax was given the nod for 12-15-year group
Covaxin was earlier approved for children 12-18 years of age
The two-dose regimen for ZyCoV-D was tested in 3100 healthy volunteers more than 12 years of age
Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA
If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe
The approval of this important test marks the 14th IVD to receive clearance by the CDSCO, and strengthens the company’s foundation for future growth
The tablets are available in 100 mg strength in bottle count sizes of 60
Targeted action improves quality of healing of tendon and suspensory ligament injuries in horses
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
The launch is yet another first of its kind innovation in India
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