Pharmaceutical company Mylan NV (NASDAQ:MYL) revealed on Monday the availability of Tadalafil Tablets USP, 20 mg, in the US for the treatment of pulmonary arterial hypertension to improve exercise ability.
The company said Tadalafil Tablets USP is the first generic version of the reference listed drug Adcirca from Eli Lilly and Company.
Following the final US Food and Drug Administration (FDA) approval for Tadalafil Tablets' Abbreviated New Drug Application (ANDA), the company received 180 days of marketing exclusivity for this product, which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
For the 12 months ending 31 May 2018, the US sales for Tadalafil Tablets USP, 20 mg, were approximately USD510m, according to IQVIA.
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