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EAST WINDSOR, N.J. — Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for tadalafil tablets USP, 20 mg. Aurobindo’s tadalafil tablets is an AB-rated generic equivalent to the reference listed drug, Eli Lilly’s Adcirca.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II to III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
Tadalafil tablets USP has an estimated market size of $409M for the twelve months ending December 2018 according to IMS.
