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USFDA Gives Nod to Aurobindo for Sildenafil Injection

 

Antibiotics-injection241Aurobindo 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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