FDA

US asks court to reject move to block Ranbaxy's generic Lipitor bid

US asks court to reject move to block Ranbaxy's generic Lipitor bidWashington, April 9 : The US Food and Drug Administration has asked a federal judge to throw out Mylan Inc's lawsuit to clear the way for the company's generic version of Lipitor and deny a rival bid by India's Ranbaxy Laboratories.

In a court filing this week, the FDA disputed claims Mylan made in a lawsuit filed last month in federal court in Washington to force the agency to allow it to introduce the generic version of Pfizer Inc's cholesterol-lowering drug as early as June, the Wall Street Journal reported.

FDA warns users to stop usage of sexual enhancement pills

ViagraThe Food and Drug Administration releases warning to users in order to stop using Man Up Now capsules at once as they are comprise of a variation of an active drug ingredient which is present in Viagra that can hazardously lesser blood pressure.

Man Up Now is prompted as a dietary add-on for sexual enhancement. Since Man Up Now comes in form of "herbal" and "all natural," the FDA is worried about the users who might assume the product to be harmless at the same time coming with no health risk.

Anti-Obesity Drug Contrave™ Receives FDA Advisory Approval

anti-obesity-fdaPharmaDirections appreciated Orexigen Therapeutics on receiving the FDA Advisory Board approval for their anti-obesity drug Contrave.

PharmaDirections claims it to be a proud moment with regard to Orexigen's pharmaceutical development partner and at the same time seemingly has developed and produced the first ContraveT product that completes an entire clinical development.

Orexigen achieved a major breakthrough in case of the two out of three Americans who are overweight or obese.

Lupus drug questioned by FDA

Lupus drug questioned by FDA The Food and Drug Administration (FDA) has questioned the kind of benefits that drugs related to lupus treatment provide. These drugs have been made by Human Genome Sciences Inc. and GlaxoSmithKline PLC and the FDA has said that the risks are far more in number than the benefits.

The medicine is known as Benlysta and as the FDA says, it, "appeared to be associated with an increase in death, serious adverse events" such as serious infections and adverse psychiatric events that included three suicides."

15 products suspected of heart diseases banned in China

15 products suspected of heart diseases banned in China   15 products which were made for weight-loss purposes have been banned in China. This has been done since these products said to increase risks related to heart. These products have been banned by the State Food and Drug Administration (SFDA). The report first came in China Daily.

FDA issues a nationwide alert against three drugs made by Claris

FDAThe US Food and Drug Administration (FDA) has alert against the use of three antibiotic drugs manufactured by an Ahmadabad-based drug-maker Claris Lifesciences. FDA has found contamination in these drugs.

After receiving reports of contamination, FDA recommended all the doctors and other healthcare professionals to discontinue the use of these drugs.

Claris is the manufacturer of the three drugs namely: metronidazole, ciprofloxacin and ondansetron. These drugs are manufactured in different strengths.

U.S. Food and Drug Administration considers 'Viagra for women'

U.S. Food and Drug Administration considers 'Viagra for women'According to the official reports, a U. S. Food and Drug Administration advisory panel will consider whether to approve a drug that its manufacturer says increases women's sexual desire.

The drug, called flibanserin, was developed by German pharmaceutical company Boehringer Ingelheim. Michael Sand, director of clinical research on flibanserin said the company believes "women deserve options and we're hoping flibanserin may represent a safe and effective option for many women," The Washington Post reported Monday.

50 years of creating motherhood, thanks to the tablet

Margaret SangerWe are going to celebrate motherliness. It is Mother's Day. Moreover it is the 50th anniversary of the tablets authorization by the Food and Drug Administration.

The birth control expert Margaret Sanger first saw the dream of a "wonderful pill" in the year 1912. She wanted to do more than normal to mothers. She wanted to revolutionize their lives. Her strategies had worked to some extent.

Bayer oral contraceptive approved by FDA

FDABayer HealthCare Pharmaceuticals has said that the U. S. Food and Drug Administration approved Natazia tablets that contain estrogen and progestin.

Current oral contraceptives contain ethinylestradiol, an estrogen, but Natazia contains estradiol valerate and estradiol valerate/dienogest, a progestin, to prevent pregnancy.

Cardiovascular surgical patch approved by U.S. Food and Drug Administration

FDA-AprovedApproval of the first absorbable fibrin sealant patch for use during cardiovascular surgery was announced on Monday by U. S. Food and Drug Administration.

The TachoSIl blood-clotting patch, which is eventually absorbed by the body, is used to prevent mild and moderate bleeding from small blood vessels when other standard surgical techniques are ineffective or impractical, the FDA said.

Dozens of misbranded drugs seized by U.S. Marshals

US-FDAU. S. marshals have seized a range of misbranded over-the-counter products, including gum, shampoos and creams, says the Food and Drug Administration.

A Wednesday raid by marshals occurred at Beehive Botanicals Inc. in Haywood, Wis., FDA officials informed.

The marshals confiscated creams, capsules, tablets, throat spray and several other products that the FDA alleges are unapproved new drugs in violation of federal law, officials further said.

Salmonella threat causes food recall

salmonellaThe US Food and Drug Administration have ordered a recall of foods detected with Salmonella. This type of bacteria is commonly found in Hydrolyzed Vegetable Protein, which is popularly used in processed foods.

Health officials exclaimed that the source of the strain known as Salmonella tennessee has been found to affect the Hydrolyzed Vegetable Protein (HVP) present in many food products sourced by Basic Food Flavors Inc. of Las Vegas. The ingredient acts as a flavour enhancer in many processed foods, including soups, sauces, chilies, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

Gaucher disease no more a threat as big as it used to be

FDA-APPROVEDThe U. S for quite sometime was having troubles with the treatment for the rare inherited disorder known as the Gaucher disease. The U. S Food and Drug Administration has approved Velaglucerase alfa for injection (VPRIV) for the treatment of this deadly disease which affects about 1 in 50,000 people as claimed by FDA in a press release.

FDA Warns Ranbaxy: Shares Fall by 5%

FDA Warns Ranbaxy: Shares Fall by 5%Shares of Ranbaxy Laboratories have fell down following the issue regarding criticism being faced by the drug maker for not putting in extra efforts to meet manufacturing standards despite warnings. The shares declined more than 7% in intra-day trade to 395.10 rupees; however they later improved by end of the day 5.0% lower at 404.85 rupees. The stock opened at Rs 416 and dipped to Rs 402.

FDA warns Nestle over making misleading nutritional claims

FDA warns Nestle over making misleading nutritional claims
The US Food & Drug Administration has issued a warning letter against Nestle, saying the Swiss food company has made some misleading claims about the health benefits of some of its beverages targeting children.

In its letter dated December 4, the FDA said Nestle mislabeled its Boost drink, which come in many flavors such as Vanilla, Chocolate, and Strawberry as a medical food as medical foods must be for the dietary management of a particular disorder or disease and must be used under medical supervision.

FDA Grants Fast Approval for Novartis Seasonal Flu Vaccine

FDA Grants Fast Approval for Novartis Seasonal Flu VaccineAgriflu, a seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics has been approved by the U.S. Food and Drug Administration (FDA), however, it offers no protection against the H1N1 virus, commonly known as swine flu.
 
As demonstrated by Novartis, the vaccine induces anti-body levels in the blood effective enough to prevent seasonal influenza, though further studies are still required for Agriflu, available in single dose, pre-filled syringes that do not contain preservatives, for 18-plus adults and administered as a single injection in the upper arm.

FDA warns against fake "Tamiflu" drugs sold online

FDA warns against fake "Tamiflu" drugs sold onlineFood and Drug Administration has warned against fake "Tamiflu" sold through the Internet. FDA stressed that such medicines can lead to side-effects and other health problems instead of curing swine flu.

Buying antiviral medication online from an unfamiliar company can put health of people in danger. Such fake medicines available online are not checked by anybody hence these can contain undesirable substances.  

Electronic Cigarettes Analysis Finds Toxic Substances

fdaThe U. S. Food and Drug Administration announced Wednesday that preliminary analysis of popular smoking devices known as electronic cigarettes have shown them to contain carcinogens and other toxic chemicals dangerous to humans.

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