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FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets.

Publication: PR Newswire
Publication Date: 18-APR-07
Format: Online
Delivery: Immediate Online Access

Article Excerpt
PITTSBURGH, April 18 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan's current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets. The FDA notified Mylan and all amlodipine besylate ANDA applicants that all of the unapproved amlodipine besylate ANDAs are currently blocked from approval by pediatric exclusivity and if the...

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