Lupin receives tentative US FDA approval for Tadalafil Tablets USP, 20 mg
Deepthi | Myequity news | Date : 17-12-2018 14:30:00 IST
Lupin has received tentative approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s (Lilly) Adcirca Tablets, 20 mg. About Lupin Limited
Lupin’s Tadalafil Tablets USP, 20 mg is the generic version of Lilly’s Adcirca Tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
Adcirca Tablets, 20 mg, had annual sales of approximately USD $ 503.8 million in the US (IQVIA MAT September 2018).
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.