FDA Warns Public of Extortion Scam by FDA Impersonators
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- Category: FDA
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
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- Category: FDA
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government has seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals.
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
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- Category: FDA
The U.S. Food and Drug Administration has sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
EMEA recommends suspension of the marketing authorisation of Acomplia
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- Category: EMA
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).
European Medicines Agency recommends update of product information of Tysabri
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- Category: EMA
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine.
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
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- Category: FDA
The U.S. Food and Drug Administration announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.
FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
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- Category: FDA
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
More Pharma News ...
- European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines
- EMEA recommendation on use of angiotensin II receptor antagonists during pregnancy
- FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone
- Wyeth Europa Ltd withdraws its marketing authorisation application for Pristiqs (desvenlafaxine)
- Actelion withdraws its application for an extension of indication for Zavesca
- FDA Licenses New Hemophilia Treatment
- Risk of peripheral neuropathy with Sebivo (telbivudine)