Announcement under Regulation 30 (LODR)-Press Release / Media Release

Press release dated September 16, 2022 titled 'Zydus receives tentative approval from the USFDA for Sugammadex Injection'

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PRESS RELEASE

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  • Zydus receives tentative approval from the USFDA for Sugammadex Injection Ahmedabad, India, 16 September, 2022 Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Sugammadex Injection USP 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial (US RLD: Bridion ® ).

  • Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

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