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    • Cipla gets USFDA nod...

    Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension

    Farhat NasimWritten by Farhat Nasim Published On 2019-04-30T10:00:28+05:30  |  Updated On 16 Aug 2021 7:24 AM GMT

    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.


    Also Read: Dr Reddys, Cipla arm recall drugs in US; includes 7.8 lakh vials of Testosterone Cypionate injection


    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.


    Also Read: Cipla appoints Dr Raju Mistry as Global Chief People Officer

    Ambrisentan Ambrisentan tablets chest pain Cipla endothelin receptor generic tablets generic therapeutic equivalent Gilead Sciences hypertension drugs Letairis PAH pharma pharma news pharma news india pulmonary hypertension syncope treatment of pulmonary arterial hypertension USFDA WHO 
    Source : with inputs

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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