Cipher receives tentative FDA approval for extended-release tramadol capsules
...- Cipher Pharmaceuticals Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe...
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Biovail's Tramadol ER Receives FDA Approval
...September 9, 2005 - Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that its New Drug Application (NDA) for a once-daily formulation of tramadol hydrochloride (Tramadol ER) has received final approval from the United States Food and Drug Administration (FDA). Tramadol ER has been approved...
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Biovail Announces Supply Agreement for Commercialization of Extended-Release Tramadol
...NV (Janssen), a division of Johnson & Johnson, for the marketing and distribution of Biovail's once-daily, extended-release formulation of tramadol hydrochloride in 86 countries in two regions - Central and Eastern Europe/Middle East and Latin America. Under the terms of this agreement, which...
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Cipher reports second quarter fiscal 2007 results
...(NDA) for         CIP-ISOTRETINOIN     -   Received approvable letter from the FDA pertaining to NDA for once-         daily tramadol     -   Continued progress preparing for commercialization of CIP-FENOFIBRATE         in the U.S., including commercial scale-up and...
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FDA Sends Warning Letter to Johnson & Johnson Regarding Consumer Webcast Video
...Board and Chief Executive Officer Johnson & Johnson 1125 Trenton-Harbourton Road Titusville, New Jersey 08560-0200 RE: NDA# 21-692 ULTRAM® ER (tramadol HCl) Extended-Release Tablets MACMIS # 17464 WARNING LETTER Dear Mr. Weldon: The Division of Drug Marketing, Advertising, and Communications (DDMAC)...
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See also: Fibromyalgia, Pain, Restless Legs Syndrome, Vulvodynia

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