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    • Lupin gets USFDA nod...

    Lupin gets USFDA nod for generic versions of Sensipar tablets, Omidria intraocular solution

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-07-04T09:45:42+05:30  |  Updated On 16 Aug 2021 11:18 AM IST

    Cinacalcet tablets are a generic version of Amgen Inc's Sensipar tablets in the same strengths, said Lupin.


    New Delhi: Drug firm Lupin on Wednesday said it has received approval from the US health regulator for its generic Cinacalcet tablets used for the treatment of excess parathyroid hormone.


    The company has received approval from the United States Food and Drug Administration (USFDA) for its Cinacalcet tablets in the strengths of 30 mg, 60 mg, and 90 mg, Lupin said in a filing to BSE.


    The tablets are a generic version of Amgen Inc's Sensipar tablets in the same strengths, it added.


    As per IQVIA MAT March 2019 data, Cinacalcet tablets, 30 mg, 60 mg, and 90 mg, had annual sales of around USD 1,527 million in the US, Lupin said.


    Read Also: Lupin gets tentative USFDA nod for generic version of Mirabegron ER tablets


    The tablets are indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and in hypercalcemia in adult patients with parathyroid carcinoma, it added.


    In a separate filing, Lupin said it has received approval for its Phenylephrine and Ketorolac intraocular solution, 1 per cent/0.3 per cent.


    The company's product is a generic version of Omeros Corporation's Omidria intraocular solution in the same strength, it added.


    As per IQVIA MAT March 2019 data, Phenylephrine and Ketorolac intraocular solution, 1 per cent/0.3 per cent, had annual sales of around USD 42.8 million in the US, Lupin said.


    The product is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain, it added.


    Read Also: Lupin recalls over 18000 bottles of Cefdinir for Oral Suspension in US

    AmgenCinacalcet tabletsgeneric versionintraocular solutionintraoperative miosisKetorolacLupinocularpainOmerosOmidria intraocular solutionpharmapharma newspharma news indiaphenylephrineSensiparUSFDA
    Source : PTI

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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