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迈兰推出苯妥英钠咀嚼片Dilantin仿制药

来源:生物谷 2012-12-30 15:19

2012年12月29日讯 /生物谷BIOON/ --迈兰(Mylan)宣布,苯妥英钠咀嚼片(Phenytoin Chewable Tablets)简化新药申请(ANDA)获得了FDA的批准,该药为辉瑞(Pfizer)苯妥英钠咀嚼片Dilantin的仿制药,是一种抗癫癎药、抗心律失常药。(生物谷bioon.com)

英文原文:

Mylan Launches Generic Dilantin Chewable Tablets
Mylan announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets, the generic version of Pfizer's Dilantin chewable tablets.

Dilantin is an antiepileptic indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited.

Phenytoin Chewable Tablets are available in a 50mg dosage strength and are being shipped immediately.

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