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NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)

Master — Wed, 18 Nov 2009 11:00:00 +0000

NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m.

NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)

admin — Wed, 18 Nov 2009 11:00:00 +0000

NeurogesX, Inc.

FDA Discusses Neuromed NDA Application For Exalgo

admin — Wed, 18 Nov 2009 08:00:00 +0000

Covidien (NYSE: COV) announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc.

FDA Statement On Vibrio Vulnificus In Raw Oysters

Master — Mon, 16 Nov 2009 10:00:00 +0000

Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months.

FDA OKs Menstrual Drug Lysteda

admin — Mon, 16 Nov 2009 07:00:00 +0000

Title: FDA OKs Menstrual Drug Lysteda Category: Health News Created: 11/16/2009 11:45:00 AM Last Editorial Review: 11/16/2009 11:45:22 AM

FDA OKs Menstrual Drug Lysteda

Master — Mon, 16 Nov 2009 07:00:00 +0000

Title: FDA OKs Menstrual Drug Lysteda Category: Health News Created: 11/16/2009 11:45:00 AM Last Editorial Review: 11/16/2009 11:45:22 AM

FDA Eyes Caffeinated Alcoholic Drinks

admin — Mon, 16 Nov 2009 07:00:00 +0000

Title: FDA Eyes Caffeinated Alcoholic Drinks Category: Health News Created: 11/16/2009 11:40:00 AM Last Editorial Review: 11/16/2009 11:40:04 AM

FDA Eyes Caffeinated Alcoholic Drinks

admin — Mon, 16 Nov 2009 07:00:00 +0000

Title: FDA Eyes Caffeinated Alcoholic Drinks Category: Health News Created: 11/16/2009 11:40:00 AM Last Editorial Review: 11/16/2009 11:40:04 AM

Web Giants Urge FDA to Update Ad Guidelines

Master — Mon, 16 Nov 2009 07:00:00 +0000

Title: Web Giants Urge FDA to Update Ad Guidelines Category: Health News Created: 11/13/2009 2:10:00 PM Last Editorial Review: 11/16/2009

Web Giants Urge FDA to Update Ad Guidelines

admin — Mon, 16 Nov 2009 07:00:00 +0000

Title: Web Giants Urge FDA to Update Ad Guidelines Category: Health News Created: 11/13/2009 2:10:00 PM Last Editorial Review: 11/16/2009

Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review For Intravenous Acetaminophen By Three Months

Master — Sat, 14 Nov 2009 09:00:00 +0000

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S.

Wright Medical Group, Inc. Receives FDA Approval To Market CONSERVE(R) Plus Total Hip Resurfacing System

admin — Wed, 11 Nov 2009 09:00:00 +0000

Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced that the United States Food and Drug Administration (FDA) has given approval to the Company to market its original CONSERVE® Plus Total Hip Resurfacing System

Onset Medical Receives U.S. FDA Marketing Clearance For The SoloPath™ TransFemoral Endovascular Access Catheter

Master — Tue, 10 Nov 2009 14:00:00 +0000

Onset Medical Corporation announced today the Company has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter.

FDA Approves Gloucester Pharmaceuticals’ ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma

admin — Sat, 07 Nov 2009 00:00:00 +0000

Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy

FDA Approves Labeling Update For REYATAZ(R) Capsules To Include 96-Week Data For Previously Untreated HIV-1 Infected Adult Patients

Master — Fri, 06 Nov 2009 23:00:00 +0000

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for REYATAZ® to include long-term data from the CASTLE Study.

Custom Spine Receives 510k Clearance Of Regent ACP

Master — Fri, 06 Nov 2009 10:00:00 +0000

Regent ACP, Custom Spine’s anterior cervical plate system, has received 510k Clearance from the U.S. Food and Drug Administration (FDA). This product clearance marks the latest addition to Custom Spine’s continually expanding product line

New TMS Clinic At Rush University Medical Center Offers Non-Invasive Treatment For Major Depression

Master — Fri, 06 Nov 2009 08:00:00 +0000

Rush University Medical Center has opened the Transcranial Magnetic Stimulation (TMS) Clinic to offer patients suffering from major depression a safe, effective, non-drug treatment. TMS therapy is the first FDA-approved, non-invasive antidepressant device-based treatment clinically proven for treatment of depression.

FDA Initiative Seeks to Reduce Accidental Overdoses

admin — Thu, 05 Nov 2009 07:00:00 +0000

Title: FDA Initiative Seeks to Reduce Accidental Overdoses Category: Health News Created: 11/4/2009 4:10:00 PM Last Editorial Review: 11/5/2009

FDA Awards Absorption Systems Phase II SBIR Grant For CellPort Technologies™

Master — Thu, 05 Nov 2009 03:00:00 +0000

Absorption Systems LP announced that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the U.S. Food and Drug Administration (FDA) to continue development of the company’s CellPort Technologies™ testing platform.

FDA Approves New Salix Product Exclusively In Catalent’s Zydis(R) Fast Dissolve Technology

Master — Thu, 05 Nov 2009 02:00:00 +0000

Catalent Pharma Solutions, one of the leading advanced drug delivery technology providers to the pharmaceutical industry, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv™ ODT (orally disintegrating tablets) metoclopramide HCL utilizing Catalent’s Zydis® fast dissolve technology.

FDA Issues Warning for Diabetes Drug

Master — Wed, 04 Nov 2009 07:00:00 +0000

Title: FDA Issues Warning for Diabetes Drug Category: Health News Created: 11/3/2009 12:10:00 PM Last Editorial Review: 11/4/2009

Covidien Receives FDA Approval For Oral Transmucosal Fentanyl Citrate Product

admin — Mon, 02 Nov 2009 12:00:00 +0000

Covidien (NYSE: COV), a leading global provider of healthcare products, announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes

Master — Sat, 31 Oct 2009 09:00:00 +0000

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

AcelRx Announces Successful Completion Of End-of-Phase 2 Meeting On ARX-01, Sufentanil NanoTab PCA System For Post-Operative Pain Management

admin — Sat, 31 Oct 2009 08:00:00 +0000

AcelRx Pharmaceuticals, Inc announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company’s proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route.

FDA Clears Interlace Medical’s MyoSureTM Hysteroscopic Tissue Removal System For The Treatment Of Submucosal Fibroids

admin — Fri, 30 Oct 2009 01:00:00 +0000

Interlace Medical, Inc., announced that it has received 510K clearance from the U. S