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Prescription Drugs

Positive Pharmacokinetic Study Results Of Investigational Abuse-Deterrent, Extended-Release Opioid

Alpharma presented positive results of a pharmacokinetic study of its investigational abuse-deterrent, extended-release opioid at the 26th annual scientific meeting of the American Pain Society in Washington.

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Critical Path Report Highlights Research Needed To Foster Generic Drug Development

The U.S. Food and Drug Administration issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.

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Senate Urged To Pass Strong Prescription Drug Safety Provisions

Consumers Union is urging the Senate to approve strong prescription drug-safety provisions this week in a major Food and Drug Administration bill, and resist attempts to weaken the bill when it comes to triggering quick safety action or moderating mass advertising of a new drug when there are signs of danger.

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Mylan Remains The Only Approved ANDA For All Strengths Of Amlodipine Besylate Tablets

The U.S. District Court for the District of Columbia issued a decision denying all requests for preliminary injunction related to Amlodipine Besylate Tablets and supporting FDA's position concerning Mylan's current status as the only approved ANDA for all strengths of this product.

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