USFDA Gives Nod to Aurobindo for Sildenafil Injection
Aurobindo Pharma Limited has received the approval from the US Food and Drug Administration (USFDA) to manufacture and market Sildenafil injection.
According to the company, the drug is bio-equivalent and therapeutically equivalent to the reference listed drug product Revatio (Sildenafil) Injection of Pfizer.
In a statement issued by Aurobindo Pharma, this is the ninth Abbreviated New Drug Application (ANDA) represented by 7 product classes to be approved out of Unit 5 formulations facility of the company in Hyderabad. The product will be marketed and sold by the company’s wholly owned subsidiary AuroMedics Pharma LLC.
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