Drug Approval | September 30, 2022
Lupin receives US FDA approval for Mirabegron Extended-Release tablets
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
The ANDA was filed as 'First to File' submission on NCE-1 date.
Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir
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Veda Corporate Advisors was the exclusive financial advisor to SHPL and its shareholders.
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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