Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension
Cipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis.
New Delhi: Drug major CiplaTuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Ambrisentan tablets, indicated for the treatment of pulmonary arterial hypertension.
Cipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis, the Mumbai-based company said in a BSE filing.
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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, it added.
Pulmonary hypertension (PH or PHTN) is a condition of increased blood pressure within the arteries of the lungs. Symptoms include shortness of breath, syncope, tiredness, chest pain, swelling of the legs, and a fast heartbeat. The condition may make it difficult to exercise. Onset is typically gradual.
Cipla said the US sales of Letairis tablets USP stood at USD 943 million in 2018.
"The product is available for shipping immediately," the company added.
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in markets of India, South Africa, North America, and key regulated and emerging markets. The firm is strengthened in the respiratory, anti-retroviral, urology, cardiology and CNS segments.
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