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Unapproved in Medical News

FDA Warns Drug Makers to Stop Selling Unapproved Prescription Painkillers

Action should not affect consumers or lead to shortages, the agency says,,,, TUESDAY, March 31 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday warned nine companies to stop making 14 unapproved prescription narcotic painkillers. These unapproved products pose a ...

United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs

Company Agrees to Permanent Injunction WASHINGTON, March 2 /PRNewswire-USNewswire/ -- The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapp...

Bayer Marketing Two Unapproved Aspirin Products: FDA

Warning letters issued for Bayer Heart Advantage, Bayer Women's Low Dose Aspirin + Calcium TUESDAY, Oct. 28 (HealthDay News) -- Drug giant Bayer HealthCare is illegally marketing two unapproved over-the-counter aspirin medications, the U.S. Food and Drug Administration said in warning...

LegalView Reports Cancer Risk for St. Louis Residents After Unapproved Asbestos Removal During Demolition

LegalView recently informed mesothelioma blog readers of improper removal of asbestos in St. Louis that may have left thousands of residents at risk for developing mesothelioma cancer. The city used an unapproved "wet method" of removing asbestos fibers, which may expose residents to th...

Avalere Report Shows Unapproved Prescription Drugs Dropped from CMS Formulary Reference File

WASHINGTON, May 15 /PRNewswire/ -- A new report, funded and released by Avalere Health, showed that CMS dropped more than 1,500 drug codes from its CY 2008 Part D Formulary Reference File. In response, commercial health plans dropped many of these drugs from their Medicare offerings in 2008, r...

FDA Cracks Down on Unapproved Cough Medicines

Some 200 prescription drugs with hydrocodone could be involved FRIDAY, Sept. 29 (HealthDay News) -- U.S. health officials announced Friday a crackdown on drug companies that make unapproved prescription drugs containing the narcotic hydrocodone, which is used as a cough suppressant an...

Raids By US Marshals Uncovers Cache’ Of Unapproved Drug

US Marshals in a raid seize $55,000 worth of unapproved dietary supplements in the form of capsules.// It had been reported that the Food and Drug Administration (FDA) agency had requested for the raid. It was found that the Advantage Nutraceuticals L.L.C distributed the capsules. Source...

FDA cracks the whip on manufacturers of unapproved Cold Medicines

The Food and Drug Administration has issued a warning to the manufacturers of unauthorized medicines for cough and cold which include the drug carbinoxamine. // The companies have been given time from 30 to 90 days by which time they should completely stop selling these medicines. The FDA anno...

Health Canada Gave Access To Unapproved Drugs To AIDS/HIV Patients.

In Vancouver Health Canada gives access to the usage of two drugs in a rare medical trail. These drugs were necessary to help prevent men dying of AIDS. // They are anti-retroviral drugs which have been studied individually but there action together is not been reviewed. These drugs are unapprov...

Drug regulatory officials giving the nod for sale of Unapproved drug formulations in India

In a recent court hearing over nimesulide, a controversial non-steroidal anti-inflammatory drug prescribed in India to treat // fever and pain the health ministry admitted that drug formulations unapproved by India’s drug regulatory agency and not evaluated for effectiveness are prescribed and sold...
Unapproved in Medical Technology

Major Manufacturer of Unapproved and Adulterated Drugs

ROCKVILLE, Md., April 25, 2007-The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of sci...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

...d study, 69 people with type 2 diabetes who were treated with exenatide (5 mcg BID for 4 weeks and 10 mcg BID to 20 mcg TID (20 mcg TID is a currently unapproved dosage of the marketed formulation of exenatide, BYETTA(R) (exenatide) injection) for the remainder of the year) or insulin glargine (both with metfor...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

...d study, 69 people with type 2 diabetes who were treated with exenatide (5 mcg BID for 4 weeks and 10 mcg BID to 20 mcg TID (20 mcg TID is a currently unapproved dosage of the marketed formulation of exenatide, BYETTA(R) (exenatide) injection) for the remainder of the year) or insulin glargine (both with metfor...
Unapproved in Medical Definition

Anthrax Vaccine Immunization Program

...e Defense Department has failed to follow presidential orders and federal laws that require the government to obtain informed consent before giving an unapproved and experimental vaccine to anyone. References ^ "Anthrax Vaccine, GEO's Survey of Guard and Reserve Pilots and Aircrew" United St...
Unapproved in Biological News

Iowa Staters talk biofuels, healthy oils and 'pharma crops' at AAAS meeting

... producing medicines and chemicals in non-food crops is more economical and less risky than using food crops. Wisner also noted several instances when unapproved genetically modified crops were found in food supplies. In those instances, Wisner said there were major disruptions in grain export markets, price im...

FDA Warns About Antipsychotic Drugs and Elderly

...n (FDA) today issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., "off-label") use of certain drugs called "atypical antipsychotic drugs." These drugs are approved for the treatment of schizophrenia and mania,...

FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media

... The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. The use of these products could r...
Unapproved in Biological Technology

FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostics Business

...the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a deter...

Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma

...pecia areata and has a rich history of use in dermatology dating back to the 1950s. To date, topical nitrogen mustard has only been available through unapproved and pharmacy compounded products, creating significant access and payment issues for many patients. Clearazide is a proprietary, cosmetically-elegant...

$425 Million Cephalon Civil Settlement and Criminal Fine; In America's Largest

...en FDA-approved. Instead, Cephalon focused its national marketing muscle on unapproved uses, targeting medical specialists with bigger patient populations, accord...ose for which approval has been received but marketing to induce off-label, unapproved use is not permitted. Under Medicaid, the state-and-federally underwritte...

Bio-Identical Hormone Menopause Doctor Responds to Outrageous FDA News

...to their news release, the FDA does not approve of the use of the estrogen estriol in any compounded formula. They consider this the manufacture of an unapproved drug. "This is certainly news to me, since estriol is one of the types of hormones naturally found in a woman's body. For the FDA to say that menopaus...
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