Cipla receives USFDA approval for Ambrisentan


Cipla has received the final USFDA approval for the Abbreviated New Drug Application (ANDA) for their Ambrisentan Tablets, 5 mg and 10 mg. The drug is a an AB-rated generic therapeutic equivalent version of Gilead Sciences’ Letairis. It is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. According to market estimates, US sales of Letairis Tablets USP stood at $943 million in 2018.

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