Pharma Medical News about Drug Approval

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FDA Issues Proposed Rule on CGMPs for Combination Drug Products
Pharmaceutical Technology, 10/14/09

Drakulich A – The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23, 2009, Federal Register. The proposed rule is meant to set forth "a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ‘single–entity’ and 'co–packaged' combination products," according to the notice.

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Mylan Receives FDA Approval for Generic Version of Prevacid Through its Subsidiary Matrix Laboratories
Mylan, 11/11/09 Relevance Score: 70%

Teva Receives Final Approval For Generic Prevacid Delayed-Release Capsules
Teva Pharmaceutical Industries, 11/11/09 Relevance Score: 70%

Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product
Covidien, 11/05/09 Relevance Score: 70%

Ultimate Fate of Oncology Drugs Approved by the US Food and Drug Administration Without a Randomized Trial
Journal of Clinical Oncology, 10/16/09 Relevance Score: 70%

Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment SinemetÂ
Mylan, 10/01/09 Relevance Score: 70%