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FDA Approvals - St. Jude Medical Announces FDA Clearance And CE Mark Approval


St. Jude Medical Announces FDA Clearance And CE Mark Approval Of Strada Carotid Guiding Sheath (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

Amneal Pharmaceuticals Receives US FDA Approval For Three Generic Prescription Drugs; Two Using New FDA Electronic ... (PharmaceuticalOnline)
Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks. Two of these products were filed during 2007 using the FDA's evolutionary eCTD/QbR/QOS format that enabled approvals in less than twelve months.
 

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