- Mylan2010年6月8日 9:30 点击：3072
Mylan Labs宣布，旗下子公司Matrix LaboratoriES Limited申请上市的学名药Gabapentin获得美国FDA最後核准，药剂量包括600 mg与800 mg，Gabapentin为辉瑞(PFE) Neurontin的学名版。Gabapentin到2010年3/31日为止12个月在美国销售额约1.74亿美元；Neurontin治疗截肢后神经痛幻觉痛。
June 4, 2010
Mylan Receives Approval for Generic Version of Neurontin(R) Tablets
PITTSBURGH, June 4, 2010 /PRNewswire via COMTEX News Network/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg, the generic version of Pfizer's Neurontin(R) Tablets for the treatment of postherpetic neuralgia, a complication of shingles. The product will be distributed by Mylan Pharmaceuticals Inc.
Gabapentin Tablets had U.S. sales of approximately $174 million for the 12 months ending March 31, 2010, according to IMS Health.
Currently, Mylan has 140 ANDAs pending FDA approval representing $95.5 billion in annual brand sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing 21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.
SOURCE Mylan Inc.
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