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    • Cipla gets FDA...

    Cipla gets FDA approval for generic Pulmicort Respules to treat asthma

    Written by Ruby Khatun Khatun Published On 2017-11-19T10:01:05+05:30  |  Updated On 19 Nov 2017 10:01 AM IST
    Cipla gets FDA approval for generic Pulmicort Respules to treat asthma

    New Delhi: Drug major Cipla said it has received final approval from the US health regulator for a suspension product used for the treatment of asthma.


    In a BSE filing, Cipla said, "it has received final approval for its abbreviated new drug application (ANDA) for Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (USFDA)".


    The approved product is a generic version of AstraZeneca's Pulmicort Respules, it added.


    Pulmicort Respules is indicated for maintenance treatment of asthma and as prophylactic therapy in children of 12 months to 8 years.


    Citing IMS Health data, Cipla said Pulmicort Respules and generic equivalents had US sales of approximately USD 825 million for the 12 months to September 2017.

    Abbreviated New Drug ApplicationANDAapprovalasthmaAstraZenecaBudesonide Inhalation SuspensionCiplaFDAgenericindian pharma newspharma newspharma news indiaprophylactic therapyPulmicort RespulesUSFDA
    Source : PTI

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    Ruby Khatun Khatun
    Ruby Khatun Khatun
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