FDA in Medical News

Covidien receives FDA clearance for its Puritan Bennett 840 ventilator system

Covidien (NYSE: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Leak Compensation software feature for the P...

Chesson Labs Liquid Bandage Product NUVADERM(TM) Receives FDA 510(k) Market Clearance

DURHAM, N.C., Aug. 5 /PRNewswire/ -- Chesson Labs today announced receiving 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for NUVADERM(TM), the Company's liquid bandage product. The 510(k) clearance allows Chesson Labs to market and sell the product for use by...

Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Aug. 4 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN ) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), issued a statement in response to the Food and Drug Administration (FDA) announcement regarding the results of a safety rev...

CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone Los Angeles, CA (PRWEB) -- For the first time t...

Veracord Delivers FDA Expertise with SyberWorks Latest Learning Management Solution

Veracord™, ( www.veracord.com ), a privately held consulting company, announced today its marketing partnership with SyberWorks Incorporated, a leader in custom Learning Management System solutions. Veracord's comprehensive validation and compliance expertise extends the SyberWorks web-base...

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG

MORRISTOWN, N.J., Aug. 3 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration...

Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

ALLEGAN, Mich., Aug. 3 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO ; TASE) today announced that its partner Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ) (previously Barr Laboratories Inc.) has received final approval from the U.S. Food and Drug Administration ...

Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

NEW YORK, Aug. 3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathw...

North Florida Sculptra Expert, Richard Sadove MD, Comments on FDA Approval

GAINESVILLE, Fla., July 31 /PRNewswire/ -- Sanofi-aventis US announced yesterday that the FDA approved Sculptra for the correction of facial wrinkles in healthy patients in the USA. It offers results that last for years. Dr Sadove, a Gainesville Plastic Surgeon, has 7 years of experience...

PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP

COLUMBUS, Ohio, July 31 /PRNewswire/ -- PharmaForce, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, a ...

Industry And FDA Leaders To Discuss The Evolving Science Of Cardiovascular Safety (CV) And Diabetic Drug Development

The Drug Information Association (DIA) will host a two-day workshop on Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications from September 23-24, 2009 in Washington, DC. Horsham, PA, (PRWEB) July 29, 2009 -- The Drug Information Association (D...

Mylan Reports That the FDA Determined That All Accusations Were Unfounded

PITTSBURGH, July 28 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today reported that in addition to the press release it issued on Sunday, the company proactively and as a courtesy had contacted the U.S. Food and Drug Administration (FDA) over the weekend to bring to its attention a ...

Ecigarettesnational.com Says Claim by FDA and Other Health Organizations Intentionally Misleading

GAINESVILLE, Fla., July 28 /PRNewswire/ -- As the FDA put out a news release concerning its stance on electronic cigarette products last week, the administration only tested two different brands. What many e-cigarette users say is important about these brands is that they are m...

Neusoft Medical's Latest Innovation, NeuViz 16 CT Scanner, Approved by FDA for the U.S. Market

SHENYANG, China, July 24 /PRNewswire-Asia/ -- Neusoft Medical Systems Co., Ltd. (Neusoft Medical), a wholly owned subsidiary of Neusoft Corporation (600718.SH), officially announced that its newly developed Computed Tomography(CT) system, NeuViz 16 multi-slice CT scanner, has been approved by ...

Elekta CMS Software Receives FDA 510(k) Clearance for Monaco VMAT Treatment Planning Solution

ANAHEIM, Calif., July 24 /PRNewswire/ -- Elekta CMS Software has received FDA 510(k) clearance for the VMAT enhancement to Monaco((R)), an advanced IMRT treatment planning solution that combines new levels of scientific insight with precise dose control. Monaco with VMAT can op...

RESPONSE to the FDA and Public Health Experts Findings on Electronic Cigarettes

LOS ANGELES, July 23 /PRNewswire/ -- Yesterday, the FDA announced that after laboratory analysis of electronic cigarette samples they have discovered that Electronic Cigarettes contain carcinogens and toxic chemicals. However, this does not ring true for U.S. based manufactu...

FDLI Publishes New FDA Directory With Obama Appointees

WASHINGTON, July 23 /PRNewswire-USNewswire/ --The Food and Drug Institute (FDLI) has just published its 2009 FDA Directory, Issue #2, which features updated biographical information on recent Obama Administration appointees, including FDA Commissioner Dr. Margaret Hamburg and FDA Deputy ...

E-Cigarettes Pose a Health Hazard, FDA Warns

Agency says testing shows devices contain carcinogens, other toxins WEDNESDAY, July 22 (HealthDay News) -- Testing of electronic cigarettes, known as e-cigarettes, has shown that they contain cancer-causing chemicals and other toxins, including a compound used in antifreeze, U.S. healt...

For Medical Device Makers, Full Spectrum Software Presents a Live, One Hour Audio Course on Implementing QA Automation in an FDA Controlled Environment

For medical device makers, Full Spectrum Software presents a live, one hour audio course on Implementing QA Automation in an FDA Controlled Environment. The event is hosted by Foreign Exchange Translations. detailed information on the course can be found here Southbor...

Masimo Receives FDA Clearance for New Rainbow(R) Resposable(TM) Sensor System

IRVINE, Calif., July 21 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI ), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced the FDA 510(k) clearance of its new Masimo Rainbow Resposable(TM) Sensor System, a revolutio...

Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume

MONROVIA, Calif., July 21 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) Divis...

Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume

MONROVIA, Calif., July 21 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) Divis...

Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol

PITTSBURGH, July 20 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for ...

Labopharm receives complete response letter from the U.S. FDA for novel antidepressant

LAVAL, QC, July 20 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS ) today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone....

Nycomed Announces FDA Filing for Daxas(R) in COPD

ZURICH, July 20 /PRNewswire/ -- N y comed tod a y announced t h e su b mission of a N e w Dru g Application (NDA) to the US Food a n d Drug Administr a tion ( F DA) for Da xas (R) as a on c e-da...

-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-

SAN DIEGO, July 20 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ) today announced that all three remaining Phase 3 trials evaluating Contrave(R) (bupropion SR/naltrexone SR), its investigational drug for the treatment of obesity, met their ...

Waging War on Wrinkles: Infini Cosmetic Associates Now Offers Recent FDA Approved Dysport - The Botox Alternative

Infini Cosmetic Associates in Scottsdale will carry Dysport™ the newly FDA approved wrinkle remover and rival to Botox®. Founder and Chief Surgeon, Dr. William Hall has performed thousands of injections over the last six years and trained many other professionals on Botox® and other...

Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)

PITTSBURGH, July 16 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tab...

Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding DOXIL(R) for Treatment of Advanced Breast Cancer

HORSHAM, Pa., July 15 /PRNewswire/ -- Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of DOXIL(R) (doxorubicin HCI liposome injection) and docetaxel did not p...

Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding Trabectedin for Relapsed Ovarian Cancer

HORSHAM, Pa., July 15 /PRNewswire/ -- Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of trabectedin when administered with DOXIL(R) (doxorubicin HCI liposome injection) did not provide a...

Nonin Medical Announces FDA Clearance for its Next-Generation Regional Oximetry System

MINNEAPOLIS, July 13 /PRNewswire/ -- Nonin Medical, Inc., a leading innovator of noninvasive physiological monitoring solutions, announced FDA clearance for its Model 7600 Regional Oximetry System. Introduced in June 2009 at the European Society of Anaesthesiology (ESA) conference in Mi...

Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges

ALLEGAN, Mich., July 13 /PRNewswire-FirstCall/ -- The Perrigo Company (Nasdaq: PRGO ; TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex lozenge USP, 2 mg and 4 mg in cherry and cinn...

Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review

SAN DIEGO, July 13 /PRNewswire/ -- Victory Pharma, Inc. ("Victory") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Victory's lead investigational rug, MGX006. If approved, MGX006 will provide patients and healt...

Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection

SUNNYVALE, Calif., July 13 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD ) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) C. difficile test, an on-demand molecular diagnostic test designed for 45-minute detection of the bac...

Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)

PARSIPPANY, N.J. and INDIANAPOLIS, July 10 /PRNewswire-FirstCall/ -- Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY ) today announced that the U.S. Food and Drug Administration (FDA) approved Effient(TM) (prasugrel) tablets for the reduction of thrombotic cardiovascular events (incl...

Cochlear Americas Announces FDA Clearance of the Cochlear(TM) Baha(R) BP100 Sound Processor, the Industry's First Programmable Bone Conduction Hearing Solution

DENVER, July 10 /PRNewswire/ -- Cochlear Americas announced today that the U.S. Food and Drug Administration (FDA) has cleared the Cochlear(TM) Baha(R) BP100 Sound Processor, the industry's first programmable bone conduction hearing solution. The Baha BP100 is an excellent choice for many children...

DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing

August 11-12 in Philadelphia, PA Horsham, PA (Vocus) -- The Drug Information Association (DIA), in collaboration with the Generic Pharmaceutical Association (GPhA), PhRMA, and the Consumer Healthcare Products Association (CHPA), will host eDrug Listing and Establishm...

Life Spine(R) Announces FDA Clearance of FS3(TM) Minimally Invasive Spinal System

HOFFMAN ESTATES, Ill., July 9 /PRNewswire/ -- Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the FS3 Minimally Invasive Spinal System. Available for nationwide release this August, the FS3 MIS Spinal System offers cannulated...

Watson Pharmaceuticals Receives FDA Approval for Fruit and Cinnamon Flavored Coated Nicotine Gums

MORRISTOWN, N.J., July 8 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration to ma...

Statement by Jim O'Hara, Director, Produce Safety Project, in Response to the White House Announcement on the Proposed FDA Rule on Produce Safety

WASHINGTON, July 7 /PRNewswire-USNewswire/ -- The Obama administration's commitment today to a produce safety rule is a significant public health victory for American families and farmers. Fresh fruits and vegetables are critical to a healthy lifestyle. With this rule consumers can have great...