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    Alembic Pharma bags USFDA nod for doxycycline hyclate tablets

    MD bureauWritten by MD bureau Published On 2020-03-06T09:15:00+05:30  |  Updated On 6 March 2020 2:53 PM IST
    Alembic  Pharma bags USFDA nod for doxycycline hyclate tablets

    Doxycycline hyclate tablets 20 mg have an estimated market size of USD 7 million for the 12-month period ending December 2019

    New Delhi: Alembic Pharmaceuticals recently said it has received final approval from US health regulator for its generic doxycycline hyclate tablets used for the treatment of adult periodontitis. The approval by the US Food and Drug Administration (USFDA) is for abbreviated new drug application (ANDA) doxycycline hyclate tablets of 20 mg strength, the company said in a regulatory filing.

    The approved ANDA is therapeutically equivalent to the reference listed drug product Periostat Tablets, 20 mg of Galderma Laboratories, LP, it added.

    Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis, the company said.

    Citing IQVIA data, Alembic said doxycycline hyclate tablets 20 mg have an estimated market size of USD 7 million for the 12-month period ending December 2019.

    The company has a cumulative total of 119 ANDA approvals (107 final approvals and 12 tentative approvals) from the USFDA, it said.

    Read also: Alembic Pharmaceuticals gets USFDA Approval for Azithromycin Tablets

    alembicusfdadoxycycline hyclate tabletsadult-periodontitis
    Source : PTI

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    MD bureau
    MD bureau

      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.

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