Content about SILVER SPRING

August 31, 2010

The Food and Drug Administration last week issued an information packet in preparation for a...

SILVER SPRING, Md. The Food and Drug Administration last week issued an information packet in preparation for a Sept. 14 advisory committee meeting that will address the potential abuse of dextromethorphan products and whether restrictions should be placed on the sale of those over-the-counter cough medicines.

 

Members of both the FDA Drug Safety and Risk Management Advisory Committee and the FDA Nonprescription Drugs Advisory Committee will be in attendance at the public meeting.

 

 

August 29, 2010

The Food and Drug Administration has posted a new list of drugs from its Adverse...

SILVER SPRING, Md. The Food and Drug Administration has posted a new list of drugs from its Adverse Event Reporting System, designed to address potential signals of serious risks and new safety information about drugs on the market.

August 22, 2010

The Personal Care Products Council announced in July that it is working to create formal...

SILVER SPRING, Md. —The Personal Care Products Council announced in July that it is working to create formal processes for the Food and Drug Administration to review ingredients of personal care products for safety at the request of the public and stakeholder groups, and to review all safety determinations made by the Cosmetic Ingredient Review expert panel.

August 19, 2010

Cases of food poisoning in consumers eating eggs from an Iowa-based company have prompted a...

August 17, 2010

A drug used to treat narcolepsy soon could win approval to treat the chronic pain...

August 15, 2010

The Food and Drug Administration has approved an emergency contraceptive pill made by a French...

SILVER SPRING, Md. The Food and Drug Administration has approved an emergency contraceptive pill made by a French drug maker.

 

The FDA announced the approval of Ella (ulipristal acetate), designed to prevent pregnancy when taken orally within five days of unprotected sex or contraceptive failure, though it is not designed for routine use as a contraceptive.

 

 

August 15, 2010

The Food and Drug Administration may rescind its approval of a drug used to treat...

August 12, 2010

The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription...

SILVER SPRING, Md. The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription and over-the-counter labels for proton-pump inhibitors that include new safety information about a possible increased risk of fractures of the hip, wrist and spine with the use of these medications.

 

The video is a part of the FDA’s Drug Info Rounds, “a program by pharmacists for pharmacists,” and presented by the Division of Drug Information pharmacists division of FDA.

 

 

July 22, 2010

The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected...

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.

 

The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.

 

 

July 18, 2010

Some stolen inhalers for patients with asthma and chronic obstructive pulmonary disease have turned up...

SILVER SPRING, Md. Some stolen inhalers for patients with asthma and chronic obstructive pulmonary disease have turned up in pharmacies, the Food and Drug Administration warned Friday.

Two lots of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol) were stolen from a warehouse near Richmond, Va., last August, with lot numbers 9ZP2255 – NDC 0173-0696-00 and 9ZP3325 – NDC 0173-0697-00. The inhalers recently found were the first from the stolen lots to turn up in commerce, the FDA said.

 

July 8, 2010

The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal...

May 24, 2010

Prolonged use of a common class of drugs for treating digestive problems may increase the...

SILVER SPRING, Md. Prolonged use of a common class of drugs for treating digestive problems may increase the risk of bone fractures, the Food and Drug Administration said Tuesday.

The FDA issued a warning to consumers and healthcare professionals based on a review of several epidemiological studies that long-term use of prescription and OTC proton-pump inhibitors or use of the drugs in high doses could increase the risk of fractures of the hip, wrist and spine. Information about the possible risks will be included on revised product labels for PPIs, the FDA said.

April 12, 2010

The Food and Drug Administration will start phasing out asthma and chronic obstructive pulmonary disease...

SILVER SPRING, Md. The Food and Drug Administration will start phasing out asthma and chronic obstructive pulmonary disease inhalers that contain ozone-depleting chlorofluorocarbons in less than two months, the agency announced Tuesday.

 

March 2, 2010

Consumers who often read food labels are increasingly aware of the link between diet and...

SILVER SPRING, Md. Consumers who often read food labels are increasingly aware of the link between diet and heart disease, according to the Food and Drug Administration's recent Health and Diet Survey.

The survey, which was conducted in 2008 via telephone of more than 2,500 adults in every state and the District of Columbia, noted that 91% of consumers were aware of the diet-heart disease relationship, an 8% jump since 2002.