Cipla gets final approval for generic version of Letairis

Cipla’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis, the company said in the filing.

Apr 30, 2019 03:04 IST India Infoline News Service

Cipla
Cipla Ltd and its subsidiary Cipla USA, Inc., (hereafter referred to as Cipla) announce receipt of final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (USFDA).

Cipla’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis, the company said in the filing.

Ambrisentan tablet 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, the company stated.

The US Sales of Letairis Tablets USP stood at $943mn in 2018. The product is available for shipping immediately.

Cipla Ltd is currently trading at Rs566.75, down by Rs1.7 or 0.3% from its previous closing of Rs568.45 on the BSE. The scrip opened at Rs568.55 and has touched a high and low of Rs570.60 and Rs564.85 respectively.

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