Cipla gets approval from USFDA for Ambrisentan Tablets

30 Apr 2019 Evaluate

Cipla and its subsidiary Cipla USA, Inc., have received final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (USFDA).

The company’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc.’s Letairis. 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 US Sales of Letairis Tablets USP stood at $943 million in 2018. The product is available for shipping immediately.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

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