齐达斯生命科学获得FDA批准使用阿曼塔丁延长释放囊治疗帕金森病. Zydus Lifesciences receives FDA approval for Amantadine extended-release capsules for Parkinson's disease treatment.

Zydus生命科学组织获得美国林业发展局对Amantadine延长释放胶囊的最后批准(68.5毫克)和对帕金森病治疗137毫克的初步批准。 Zydus Lifesciences receives final US FDA approval for Amantadine extended-release capsules (68.5 mg) and tentative approval for 137 mg for Parkinson's disease treatment. 该药物将在他们的艾哈迈达巴德SEZ-II设施制造,提供180天的独家治疗。 The drug will be manufactured at their Ahmedabad SEZ-II facility and offers 180 days of exclusivity. 这项批准标志着该公司第400次批准,使自2003-2004财政年度以来提交的简化新药物申请总数达到465份。 This approval marks the company's 400th approval and brings its total Abbreviated New Drug Applications (ANDAs) filed since FY 2003-04 to 465.

August 28, 2024

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