December 25, 2012
FDA Makes New Drug Approvals, Warns Of A Counterfeit One
Lee Rannals for redOrbit.com - Your Universe Online
The U.S. Food and Drug Administration (FDA) has issued announcements of its approval of new drugs before the start of the new year.
The FDA has approved a new drug to help treat high cholesterol known as Juxtapid, which helps take care of a rare genetic form of high cholesterol.
The condition, which affects about 3,000 Americans, causes super-high cholesterol levels and heart attacks at an early age. The drug injections will cost $200,000 to $300,000 annually.
"The FDA approval of JUXTAPID is a major step forward for HoFH patients and their families, who have long been waiting for new therapies," Katherine Wilemon, president and founder of The FH Foundation, said in a prepared statement. "New treatments, combined with further understanding and awareness of this disease, can bring much needed hope to the HoFH community."
According to the FDA, Varizig is now approved for reducing chicken pox symptoms. While most people are immune to the virus after getting infected, this new drug helps reduce symptoms in those who do get the life-threatening virus.
Another new drug approved by the FDA helps patients suffering from short bowel syndrome. The daily injection, known as Gattex, treats adults who have short bowel syndrome, which results from the partial surgical removal of the small or large intestine due to cancer, colitis or other conditions.
The FDA also recently announced counterfeit Botox may have been shipped to 350 clinics in the U.S.
The agency said in a letter that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA, and the agency cannot assure their effectiveness of their safety.
According to the FDA, Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. This is the fifth announcement the agency has made the year about foreign suppliers providing unapproved drugs.
"Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the FDA said in a Dec. 19 statement.
The agency warned back in February that 19 medical practices had received a counterfeit version of the cancer drug Avastin. On three more occasions, the agency issued similar warnings about counterfeit Avastin and Altuzan.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.
Genuine Botox is made by Allergan Inc., which is a California based company. The drug is made from a toxin that can be used in small doses to help remove facial wrinkles and treat other medical conditions liked cervical dystronia, which is a neurological disease that causes muscle contractions in the neck and shoulders.