Mumbai, India, February 7, 2019: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Tadalafil Tablets 20mg from the United States Food and Drug Administration (US FDA).
Cipla’s Tadalafil Tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co.’s Adcirca ®. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. According to IQVIA (IMS Health), Adcirca® and its generic equivalents had US sales of approximately $490M for the 12-month period ending November 2018. The product is available for shipping immediately.