FDA批准降压药科素亚和海捷亚的首个仿制药

FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension
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(April 7, 2010)On April 6, the U.S. Food and Drug Administration approved the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively.
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5 z) h6 T( x4 V- g8 Z5 d. HCozaar and Hyzaar tablets are widely-used antihypertensive drugs. Both generic losartan products will carry the same safety warnings as their brand counterparts. These warnings include a boxed warning against the use of these products during the second and third trimesters of pregnancy.

Losartan potassium tablets are approved in 25 milligram, 50 mg, and 100 mg strengths, and Losartan potassium and hydrochlorothiazide tablets are approved in 50 mg/12.5 mg, 100mg/12.5 mg, and 100 mg/25 mg strengths. Both products are manufactured by TEVA Pharmaceuticals USA in North Wales, Pa.
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In related actions, the FDA also approved applications from several other companies for losartan potassium and hydrochlorothiazide tablets for the 100 mg/12.5 mg strength only. These companies include Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., and Torrent Pharmaceuticals Ltd.
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, d4 L' q2 v+ k1 r5 j5 GSource:www.fda.gov
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FDA批准降压药科素亚和海捷亚的首个仿制药
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& Y: A' u; e& E" k, A( r4月6日，美国食品药品监督管理局（FDA）批准了两种用于治疗高血压药物的首个仿制版本。氯沙坦钾片和氯沙坦钾／氢氯噻嗪片（一种复方药物）分别是与Cozaar（科素亚）和Hyzaar（海捷亚）片疗效相同的仿制药。

Cozaar（科素亚）和Hyzaar（海捷亚）片是被广泛使用的降压药。这次批准的含氯沙坦的仿制药将携带与其等效品牌药相同的安全警告。这些警告包括一项有关反对在妊娠的第二、三期使用这些药品的黑框警告。

. H5 h4 m( k, s' W4 f被批准的氯沙坦钾片规格分别为25mg、50mg和100mg，氯沙坦钾／氢氯噻嗪片的规格为50 mg/12.5 mg，100mg/12.5 mg和100 mg/25 mg。两种产品均由位于美国宾夕法尼亚州North Wales的美国特瓦制药公司（TEVA Pharmaceuticals USA）生产。

( F1 K) N( u/ Y在此次相关的行动中，FDA还批准了来自其他一些公司生产的氯沙坦钾／氢氯噻嗪片的上市申请，但仅限于100 mg/12.5 mg的规格。这些公司包括Mylan制药公司、Roxane Laboratories公司和Torrent制药公司。