Archives for December 2015

FDA Approves Zurampic To Treat Gout

The FDA today approved lesinurad (Zurampic, AstraZeneca Pharmaceuticals) to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug that reduces the production of uric acid in the body.

Gout is a painful form of arthritis caused by the buildup of too much uric acid in the body, and usually appears first as redness, soreness and swelling in the big toe. Uric acid in the blood is produced from the breakdown of purines, which are found in all the body’s tissues. Uric acid usually dissolves in the blood, then passes through the kidneys and out of the body in urine. Hyperuricemia occurs when the body increases the amount of uric acid it makes, the kidneys do not eliminate enough of it or a person eats too many foods high in purines. Most people with hyperuricemia do not develop gout, but if uric acid forms crystals in the body, gout can develop.

FDA eases restrictions on blood donations from gay men

Federal health officials are lifting the nation’s 32-year-old lifetime ban on blood donations from gay and bisexual men, but major restrictions will continue to limit who can donate. The Food and Drug Administration announced Monday it will replace the blanket ban with a new policy barring donations from men who have had sex with a man in the previous year. While the one-year-ban has been criticized by activists it matches policies in other countries, including Australia, Japan and the U.K. Gay rights activists said the new policy is a “step in the right direction,” but falls short. “It continues to stigmatize gay and bisexual men,” said David Stacy, of the Human Rights Campaign, the largest U.S. gay rights group. “It simply cannot be justified in light of current scientific research and updated blood screening technology.” Monday’s policy shift was first announced in late 2014 and followed years of outreach by medical groups and gay rights groups who said the blanket ban no longer made sense. FDA officials signaled their agreement Monday, saying in a statement the change is “backed by sound science and continues to protect our blood supply.” The lifetime ban was put in place during the early years of the AIDS crisis and was in-tended to protect the blood sup-ply from what was a then little-understood disease. But many medical groups, including the American Medical Association, argued that the policy was no longer supported by science, given advances in HIV testing. All U.S. blood donations are screened for HIV, the virus that causes AIDS. But there is a roughly 10-day window be-tween initial infection and when the virus can be detected in the bloodstream. The American Red Cross estimates the risk of getting an HIV-positive blood donation is 1 in 1.5 million for U.S. patients. About 15.7 million blood donations are collected in the U.S. each year. In 2006 the Red Cross, the American Association of Blood Banks, and America’s Blood Centers called the ban “medically and scientifically unwarranted.” The FDA concluded that moving to a one-year abstinence requirement would not change the safety of the U.S. blood supply, based on data from Australia and other sources. On the current blood donor questionnaire, men are asked if they have ever had sex with another man since 1977— the start of the AIDS epidemic in the U.S. Potential donors who answer positively are barred from donating blood. The new questionnaire, as outlined by the FDA, would ask men if they have had sex with another man in the last 12 months. See More At:

Merry Christmas From Aseptic Enclosures

Wishing you a Merry Christmas  and prosperity in the New Year. We value our professional relationships and thank you for being our customer.

 We look forward to continuing our partnership in the coming year.

 All the best to you, your family and your organization.

Compounded HT prescriptions increasing

The researchers said unique risks come with compounded HT because of the lack of FDA approval and monitoring.


JoAnn Pinkerton

JoAnn V. Pinkerton

Johnson & Johnson Back in Court Over Secretive 2009 Recall of Motrin

NEW BRUNSWICK, NJ–In the spring of 2009, “secret shoppers” across the United States were discreetly buying up thousands of bottles of Motrin from the shelves of retail stores.

Babies, mothers possibly exposed to TB at California hospital

A Northern California hospital says hundreds of babies, mothers and employees may have been exposed to a nurse with tuberculosis and that the infants will need an antibiotic treatment.

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.

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