Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links
PHARMA - PHARMAKON DRUG SALES BANNED

US FDA blocks sale of Pharmakon's illegal drugs

US District Judge issues injunction against Florida company.

 

BY OUR PHARMA  CORRESPONDENT

 July 31, 2005: The USFDA has announced an injunction closing operations at Florida's Pharmakon Labs, which manufactures and sells cough and cold liquids, tablets and caplets.

The FDA move follows an inspection by its team, which showed that the company did not meet current good manufacturing practice (cGMP) standards and other legal requirements. 

Judge Lazzara said that he was "simply unwilling as a court of equity to place the health, safety, and welfare of the general public at risk in order to accommodate the economic well-being of Defendants." Thus, company 
was ordered to shut making and selling the medicine till it it complied with CGMP standards to the satisfaction of FDA.

FDA Commissioner Dr. Lester M. Crawford said: "This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards. As the nation's top enforcer of manufacturing standards, the FDA will continue to ensure that drugs being sold in this country meet those crucial requirements."

FDA said that Pharmakon has a long history of violations of American laws. The government's initial complaint alleged numerous manufacturing violations documented in four inspections dating back to 2001. FDA later added charges related to several Pharmakon drugs which are unapproved. The FDA move aganst the drug maker comes as part of the agency's policy to seek relief for all legal violations by a firm at the same time.

The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.

 

Pharma News Headlines

Cancer News

Cardiac News

US FDA News

Pharma industry news

LATEST UPDATES

New device inducing blood flow to heart granted US patent

NIH announces grants for faster, cheaper DNA sequencing

DOV starts phase III trial of pain drug in US

Alcohol linked cancers: Acetaldehyde in spot light

Hypertension `just above normal’ too risky

Gene causes infertility drugs go awry: study

China’s pig flu outbreak

Cardiac Science-Defibtech lawsuit settled

Peregrine starts Phase-1 anti-viral trial of Tarvacin

Dr. Reddy's launches immune booster for children

Lupin in pact with Kyowa of Japan

Bird flu vaccine may work in humans: US researchers

More funding for Sentinel Breastscan

New drug Provigil can keep you awake: Cephalon

Anti-virals can stem global flu outbreak: Studies

USFDA’s recall overdrive creates panic among drug users

Backjoy - A chair support that helps relieve back pain

Why does mammography lead to pain for some black women?

What after the Atkins diet?

Perrigo recalls infants’ oral drops in US

Diovan approved to treat heart failure in US

British Pharma seeks opinion on industry code

Novartis gets EU nod for Xolair

Eli Lilly to submit ruboxistaurin for diabetic vision loss

Snuppy: The first cloned dog

India bans valdecoxib

UK recalls Lipitor fakes

Drug developers set sight on 'interactome'

Ranbaxy gets US FDA nod for sumatriptan tabs

US FDA approval for Orchid's ceftriaxone vials

Pfizer's Celebrex approved for spondilitis

IVAX gets FDA okay for hydrochlorothiazide caps

Mumbai floods: Pharma sector losses estimated at Rs 1,000 crore

Calorie Control Council Statement: Allegations Against Aspartame Unfounded

European biotech start-ups fail to win late-stage funds

Ranbaxy gets USFDA nod for glimepiride tabs

Experts debate benefits of heart implant in US

US FDA blocks sale of Pharmakon's illegal drugs

Echinacea does not prevent common cold: Study

Afghan’s first generics plant to go on stream by Oct. ‘05

PhRMA seeks voluntary DTC ad code

Barr, Teva get fexofenadine approvals from US FDA

Novartis completes Eon Labs buy

Able Laboratories files bankruptcy suit with US court

Orbus inks supply pact with Docpharma 

Matrix acquires controlling stake in Docpharma

Actavis launches Fosinopril in Netherlands, Sweden &UK; Benazepril in Germany

Insomnia treatment: ROZEREM approved by FDA

Stories below archived on 25 July, 2005

Roche, Novartis lead on novel cancer therapies

US FDA grants fast track status for GSK’s HIV drug

Stem Cell Bill could be delayed in US

FDA warning on abortion drug Mifeprex (Mifepristone)

US FDA recalls Baxter’s intravenous pumps

US FDA grants tentative nod to Ranbaxy’s glimepiride

Lupin launches generic ceftriaxone in US

Hormonal contraceptives safe for long-term use: WHO

Abortion pill to carry 'black box' warning

Vaccines not linked to autism, say experts

Novartis acquires Bristol-Myers’ OTC business in US

Guidant alerts on flaw in pacemakers

Awareness on Medicare drug benefit scheme low in US

NIH review finds govt scientists having ties with pharma firms

US FDA to decide on Plan B morning-after pill by Sept 1

Painkiller patch Duragesic under US FDA probe over patients deaths

Legionnaire's disease outbreak in US hospital in New Rochelle 

Genepharm in pact with 3 Australian distributors 

UK has new generics reimbursement scheme 

Teva gets US FDA nod for mirtazapine anti-depressant 

US patent office rejects Pfizer’s Lipitor claims 

Aethlon Medical to start trials on HIV device in India 

Panel to decide fate of Advair, Serevent and Foradil asthma drugs 

Prohibitive costs mar cancer therapy 

FDA directs Palladone withdrawal

Blindness alert on impotence drugs  

Novartis files for breast cancer drug in US, Europe  

Merck readies for $10 billion Vioxx battle  

Speak up on menopause, campaign urges US women 

Direct-To-Consumer ads mislead patients: US Senator  

EU to decide on sops for developing kids drugs  

Zidovudine by Ranbaxy gets US FDA tentative nod

Parkinson's Disease therapy triggers gambling in some patients

Parkinson's Disease symptoms may be relieved by Azilect

Are obesity and diabetes just accelerated aging?

Reducing lung infection and inflammation due to Cystic Fibrosis

 

 

Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us