Food and Drug Administration

Food contact notification to FDA

Biotage AB (publ) through its subsidiary MIP Technologies AB submits Food Contact Notification (FCN) to U.S. Food and Drug Administration (FDA)

Vistide Recall for Particulate Matter

Gilead Sciences Inc. voluntarily recalled one lot of Vistide (cidofovir injection) over a possible contamination with visible particulate matter.

The recall is for lot number B120217A, according to the Food and Drug Administration. The recalled product is clear, colorless, and supplied in clear glass vials. It is used in the treatment of cytomegalovirus (CMV) retinitis in AIDS patients.

First Actos Bladder Cancer Lawsuit Starts

The first trial over the alleged bladder cancer risk of Takeda Pharmaceutical’s diabetes drug, Actos, gets underway this week in state court in Los Angeles.

First Actos Bladder Cancer Lawsuit Starts

The first trial over the alleged bladder cancer risk of Takeda Pharmaceutical’s diabetes drug, Actos, gets underway this week in state court in Los Angeles.

Reumofan Plus Tablets Recalled

A recall of Reumofan Plus Tablets was issued by Reumofan Plus USA, LLC and Reumofan USA, LLC because the tablets contain undeclared drug ingredients that can cause grave injuries.

Reumofan Plus tablets are used for conditions such as muscle pain, arthritis, osteoporosis, and bone cancer.

Zoloft Lawsuit Claims Drug is Ineffective

A lawsuit filed against drug giant Pfizer Inc. has claimed that its antidepressant drug Zoloft has no benefit for patients and that the company should refund patients for the costs of buying the drug.

Pradaxa Has Risks—Should You Take It?

Millions of Americans with an abnormal heart rhythm use the drug Pradaxa (dabigatran) daily to help prevent stroke and blood clotting. Since its approval in 2010, Pradaxa has been linked with numerous problems, including serious and potentially fatal bleeding. Pradaxa is not recommended for patients with mechanical heart valves or who are undergoing active bleeding.

Additionally, the Mayo Clinic provides warnings about the use of Pradaxa in other groups, including:

Counterfeit Botox Sparks FDA Alert

The U.S. Food and Drug Administration (FDA) issued an alert for doctors and healthcare professionals warning them that they may have purchased illicit and potentially counterfeit Botox, a drug used to temporarily erase facial lines and wrinkles.

The drug was supplied through a wholesaler network controlled by Canada Drugs, an international supplier that earlier this year was linked to fake cancer medicines, writes The Wall Street Journal.

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