PHARMACY

FDA issues complete response letter to AstraZeneca, Abbott

BY Alaric DeArment

WILMINGTON, Del. The Food and Drug Administration has declined to approve an application for a cholesterol drug from AstraZeneca and Abbott, the two drug makers announced Tuesday.

The FDA delivered the companies a complete response letter for Certriad (rosuvastatin and fenofibric acid) delayed-release capsules.

A complete response letter means that the FDA is unable to approve a drug in its current form and usually contains guidance of how to make the drug approvable, though the two companies didn’t specify what issues the agency raised.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

GSK offers free vaccines to uninsured adults

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. GlaxoSmithKline is offering its vaccines free of charge to low-income adults, the British drug maker announced Monday.

 

The GSK Vaccines Access Program offers adult vaccines for diseases such as hepatitis, tetanus and human papillomavirus for adults ages 19 years and older who lack health insurance coverage for vaccines.

 

 

“Vaccines are one of the most effective ways we can prevent and fight disease, and subsequently drive down the cost of health care in the United States,” GSK president for North America Pharmaceuticals Deirdre Connelly said. “Unfortunately, vaccines are severely underutilized by American adults.”

 

 

Children up through the age of 18 years are eligible to receive free vaccines under a separate program, Vaccines for Children, which receives federal funding.

 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

NBA Cares takes vaccination awareness program to Detroit

BY Allison Cerra

DETROIT The charitable arm of the NBA is expanding its education program about adolescent vaccinations to Detroit.

Detroit Pistons forward Jonas Jerebko and NBA Legend Bob Lanier teamed up with NBA Cares and the Society for Adolescent Medicine to bring Vaccines for Teens to the Metro Detroit community. Vaccines for Teens is a national multimedia campaign designed to educate teens and their parents about the importance of vaccination against serious and potentially life-threatening diseases.

To tip off the campaign locally, Jerebko and Lanier appeared at the Arts and Technology Academy in Pontiac, Mich., to urge parents of preteens and teens to discuss adolescent vaccinations with their family physicians.

Teens are at risk for influenza disease, both seasonal and the influenza A (H1N1) virus, as well as for other serious infectious diseases such as meningococcal disease (including meningitis) and whooping cough (pertussis). The basketball superstar and local community leaders agree it is more important than ever to help protect preteens and teens in the Metro Detroit area from the potentially life-threatening complications of these diseases.

“Vaccination can help teens grow into healthy adults, and is beneficial for the students at Arts and Technology Academy of Pontiac and for teens throughout the Metro Detroit area,” said Jerebko. “In basketball, the best offense is a good defense, and the same holds true for protecting teen health.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES