Drug Approval | October 27, 2022
USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
The CRL did not identify any outstanding scientific issues with the product.
The CRL did not identify any outstanding scientific issues with the product.
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
Sitagliptin is an active ingredient in JANUVIA, JANUMET and JANUMET XR
The product will be launched by NATCO's commercial partner Viatris.
ICICI Direct expects revenue CAGR of 35.6% over FY22-FY24E mainly due to the consolidation of Viatris business and they expect EBITDA margin expansion of 230bps and earnings CAGR of 64.8% over FY22-FY24E
The product will be manufactured at Lupin’s facility in Goa, India
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The Indian companies that have been granted licences are Cipla, Sun Pharma, Laurus Labs, Divis Labs, Glenmark, Cadila, Torrent, Emcure, McLeods, SMS Pharmaceuticals, Strides, Biocon, Aurobindo Pharma, Hetero, Granules, Amneal, MSN, Arene Life Sciences and Viatris
Decisions reaffirm the ability of Biocon Biologics and Viatris to provide patient access to interchangeable Semglee
Biocon Biologics and Viatris co-developed the products
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