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Biovail Corp. is in the Pharma Industry
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Biovail Confirms FDA Class 2 Status For BVF-033 Submission
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today confirmed that the U.S. Food and Drug Administration FDA has classified the response submitted by the Company October 23, 2007, to the FDA Action Letter for BVF-033, its novel salt formulation of bupropion, as Class 2.
Biovail Submits Complete Response to FDA for BVF-033
TORONTO -- Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that the Company has submitted a Complete Response to the United States Food and Drug Administration FDA that addresses all the issues raised in the Non-Approval Letter for BVF-033, a novel once-daily salt formulation of bupropion.
Biovail Provides Update on BVF-033
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received a Non-Approval letter from the U.S. Food and Drug Administration FDA for its New Drug Application NDA for BVF-033, a novel once-daily salt formulation of bupropion. The main issue raised by the FDA in its letter related to the...
Biovail Commences Legal Action to Enforce Criteria Set Forth in Its Citizen Petition
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has filed suit against the U.S. Food and Drug Administration FDA in the United States District Court for the District of Columbia. Biovail's legal action refers to its Citizen Petition filed with the FDA on December 20, 2005. That Citizen Petition...
Biovail Receives FDA Approval for Citalopram ODT
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received an Approval Letter from the United States Food and Drug Administration FDA for its New Drug Application for an orally disintegrating tablet formulation of citalopram hydrobromide HBr for the treatment of depression.
Biovail Submits Citizen Petition to FDA
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today the submission of a Citizen Petition with the Food and Drug Administration FDA to require rigorous bioequivalence testing for generic products that reference Wellbutrin XLR before they can be approved. Biovail has taken this step to protect patients against potentially serious risks (particularly...
Biovail Receives FDA Approval for Citalopram ODT.
TORONTO, Dec 21, 2005 CCNMatthews via COMTEX -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received an Approval Letter from the United States Food and Drug Administration FDA for its New Drug Application for an orally dis TORONTO, Dec 21, 2005 CCNMatthews via COMTEX --...
Biovail Exclusivity for Tramadol ER Confirmed by FDA
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that the United States Food and Drug Administration FDA has confirmed - and has posted on its Orange Book Web site - that Biovail's once-daily extended-release formulation of tramadol Tramadol ER has received three years of exclusivity, covering all dosages.
Biovail Exclusivity for Tramadol ER Confirmed by FDA.
TORONTO, Oct 21, 2005 CCNMatthews via COMTEX -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that the United States Food and Drug Administration FDA has confirmed - and has posted on its Orange Book Web site - that Biovail's once-daily TORONTO, Oct 21, 2005 CCNMatthews via COMTEX --...
Biovail's Tramadol ER Receives FDA Approval
TORONTO -- 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.
Biovail, Depomed Receive FDA Approval for Extended-Release Glumetza for Type II Diabetes; Enhanced Formulation to Offer Physicians Potential Advantages
TORONTO and MENLO PARK, Calif. -- Biovail Corporation (NYSE:BVF)(TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that they have received an Approval Letter from the United States Food and Drug Administration FDA for GlumetzaTM, a once-daily, extended-release formulation of metformin hydrochloride HCl for the treatment of Type II diabetes.
Stocks to Watch: Celgene, 51job, Biovail.
M2 PRESSWIRE-27 May 2005-SmallCapReview: Stocks to Watch: Celgene, 51job, BiovailC1994-2005 M2 COMMUNICATIONS LTD RDATE:27052005 Celgene (Nasdaq: CELG) Announced that Novartis Pharma AG, its partner in the development and commercialization of FOCALIN XR, was granted U.S. Food and Drug Administration FDA approval...
Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received tentative approval from the United States Food and Drug Administration FDA for its New Drug Application NDA for its oral disintegrating tablet ODT formulation of zolpidem tartrate, which is indicated for the short-term treatment of insomnia.
Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders.
TORONTO, May 27, 2005 CCNMatthews via COMTEX TORONTO, May 27, 2005 CCNMatthews via COMTEX
Biovail Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version to Provide Treatment Option for Those Who Suffer from Moderate to Moderately Severe Pain
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an Approval Letter from the United States Food & Drug Administration FDA for Tramadol ODT tramadol hydrochloride, an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride in 50mg dosage format, intended for the treatment of moderate to...
Biovail Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version to Provide Treatment Option for Those Who Suffer from Moderate to Moderately Severe Pain.
TORONTO, May 6, 2005 CCNMatthews via COMTEX TORONTO, May 6, 2005 CCNMatthews via COMTEX
Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes
TORONTO and MENLO PARK, Calif. -- Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that they have received an Approvable Letter from the United States Food and Drug Administration FDA regarding a New Drug Application NDA for GlumetzaTM, a once-daily, extended-release formulation of metformin hydrochloride HCl for the...
Biovail Confirms Receipt of Notification of ANDA Submission for Wellbutrin XL
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today confirmed that it has received notification that an abbreviated new drug application ANDA has been submitted to the U.S. Food and Drug Administration FDA by Anchen Pharmaceuticals, Inc., seeking marketing approval for 150mg and 300mg generic formulations of Wellbutrin XLR (once-daily bupropion). At the...
Biovail's Ralivia ER Receives Approvable Letter From FDA
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an Approvable Letter from the United States Food & Drug Administration FDA for its New Drug Application NDA for Ralivia ERTM tramadol hydrochloride extended-release tablets, a once-daily oral controlled-release pain medication.
Biovail's Ralivia ER Receives Approvable Letter From FDA.
TORONTO, Nov 1, 2004 CCNMatthews via COMTEX TORONTO, Nov 1, 2004 CCNMatthews via COMTEX
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Biovail Corp. Company Info
NAICS Code
Pharmaceutical Preparation Manufacturing: 325412
