Drug Approval | September 30, 2022
Lupin launches Sildenafil for Oral Suspension in US
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
Pfizer’s Paxlovid is approved by US FDA for COVID treatment
The unit has filed 2 Derma products and 1 MDI product.
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
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