Submit Clinical Comparative Data: CDSCO panel tells Abbott Healthcare On Metronidazole ER Tablet
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New Delhi: Citing that the drug major Abbott Healthcare did not present any comparative clinical data of proposed drug product, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit comparative clinical data of proposed drug product i.e. Metronidazole Extended Release Tablets 600mg (Proposed dose: 2 x 600mg OD) with Metronidazole conventional Tablets 400mg (TS) with respect to proposed additional indication.
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