Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Monday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for generic versions of Revatio (sildenafil citrate) and Amicar (aminocaproic acid).
Following the US FDA approval, the company has initiated the commercialization activities for Revatio for oral suspension in 10 mg/ml and Amicar tablets USP in 500 mg.
The company has received the US FDA Competitive Generic Therapy (CGT) designation for the generic version of Amicar and under the first approved application, the tablet has been granted with 180 days of CGT exclusivity.
For the 12 months ended 30 September 2019, the US market annual sales for the company's sildenafil citrate oral suspension and aminocaproic acid 500 mg tablets were estimated at about USD180m and USD23m, respectively, according to IQVIA,
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