FDA Warns Vertex About Misleading Incivek Marketing Claims
The Food and Drug Administration has issued a warning letter concerning potential marketing materials of a drug meant to treat hepatitis C. The drug in question is called Incivek, and it is manufactured by Vertex Pharmaceuticals. The FDA took issue with a potential marketing event in which a patient would be extolling the virtues of… read more
FDA Asks Pfizer To Pull Misleading EpiPen Television Ad
The Food and Drug Administration is warning Pfizer that one of their ads has the potential to mislead consumers. The ad in question is used as marketing material for the company’s EpiPen and EpiPen Jr Auto Injectors. In the television ad that the FDA accuses of being misleading, a mother and a child are talking… read more
FDA Admonishes McNeil For Not Addressing Consumer Complaints
The Food and Drug Administration has some serious concerns about the safety procedures that a pharmaceutical giant has in place for handling complaints. The McNeil division of Johnson & Johnson has been the recipient of a warning letter from the safety agency. The FDA believes that this division failed to properly look into hundreds of… read more
FDA Panel Advises Against Xarelto Approval
Going against the opinion of one of the Food and Drug Administration’s drug reviewers, an advisory panel opted to vote against the approval of a potential blood thinner medication. The drug in question is called Xarelto (rivaroxaban). Already on the market for a couple other conditions, its maker was hoping to gain approval to to… read more
Franck’s Pharmacy Recalls All Prescriptions Due To Contamination
Those persons who follow recall information regularly likely heard recently about a recall involving certain products that had been manufactured at a place called Franck’s Pharmacy. Now, that same company is issuing another recall. This time, the recall affects every single sterile human or veterinary prescription that Franck’s distributed between November 21 of last year… read more
FDA Drug Reviewers Advise Against Approval of Pfizer’s Tafamadis
A pill designed by Pfizer to help those with a certain deadly medical condition is facing an advisory panel composed of outside experts on Thursday, and in the lead-up, the pill already has one strike against it. Drug reviewers from the Food and Drug Administration have advised not approving the drug known as tafamidis. That’s… read more
FDA Promotes Efforts to Keep Kids Safe from Drug Dangers
Because medications often react differently in adults and children, parents need to be aware of the risks and benefits of doling out certain drugs to their little ones. And the Food and Drug Administration wants to prepare adults with the information they need to ensure their children are safe. To that end, they’re promoting the… read more
Drug Study Results Could Mean Improvements in Allergy Prevention
The Food and Drug Administration is touting the results of a study that they say can help them combat severe allergic reactions that patients might have when exposed to certain drugs. The results of the FDA-led research were published in a journal called AIDS. Researchers discovered that Ziagen (abacavir), which is used to fight the… read more
FDA Could Approve Xarelto Despite Internal Bleeding Risk
A drug that could help prevent blood clots in certain persons is going to be reviewed on Wednesday, and even though the Food and Drug Administration is cautiously optimistic about its approval, officials still have worries. Johnson & Johnson is the maker of the drug, which is called Xarelto. The drug is already on the… read more
FDA Looking Into Risks Associated with Azithromycin
The results of a new drug study have prompted the Food and Drug Administration to issue a statement regarding where they stand on the product’s risk potential. The New England Journal of Medicine today released a report that detailed how persons who were given a five day course of the drug known as azithromycin, such… read more
FDA Warns Against Taking Fingolimid with Certain Meds
In a demonstration of how crucial it is for tests to be conducted even after a drug is proven safe, the Food and Drug Administration is warning consumers about a drug that might react negatively with another substance. The organization recently received a report about a person dying after being administered the first dose of… read more
Congress Considers Bill That Extends FDA’s Foreign Inspection Power
A seeming inability of the Food and Drug Administration to properly police pharmaceutical factories in other countries has led some lawmakers to offer up a solution. A Pennsylvanian Congressman has put forth a bill that would provide critical funding to allow the FDA to conduct more inspections in drug factories abroad. The bill, known as… read more
