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Drug safety: Isotretinoin makers to comply with new FDA monitoring plan
May 1st 2008Manufacturers of isotretinoin are awaiting more information to determine whether iPLEDGE - the mandatory federal drug registry already in place - will meet the Food and Drug Administration's new safety plan requirements.
What's new in psoriasis therapy
May 1st 2008Some current therapies of psoriasis, though effective, are marred by their poor safety profile. A new experimental drug, similar in molecular structure to cyclosporine, has been shown to be safe and effective in the treatment of moderate to severe chronic plaque psoriasis.
FDA removes screening, monitoring requirement for acne drug
April 1st 2008Washington - The Food and Drug Administration (FDA) has removed a blood-screening and monitoring requirement for Aczone, a topical acne treatment manufactured by QLT USA, a unit of biotech company QLT Inc., Vancouver, British Columbia, the Associated Press reports.
Small prospective trial suggests effectiveness of newly developed frostbite treatment
April 1st 2008St. Paul, Minn. - Using imaging to visualize areas lacking blood flow and deliver clot-breaking, anti-spasmodic drugs via catheter has proved to be an effective treatment for people who suffer severe frostbite, Newswise.com reports.
Johnson & Johnson receives FDA approvable letter for ceftobiprole
April 1st 2008Raritan, N.J. - Johnson & Johnson Pharmaceutical Research & Development has received a Food and Drug Administration (FDA) approvable letter for ceftobiprole, an antibiotic used to treat skin infections, according to an Associated Press report.
Peanut allergy linked to sensitization through skin
April 1st 2008Philadelphia - The mechanism leading to the development of peanut allergy and a potential desensitization treatment for peanut-allergic individuals were among the study findings presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting held here in March, HealthDay News reports.
Ipsen submits BLA to FDA for Reloxin
April 1st 2008Scottsdale, Ariz. - Medicis and Paris-based Ipsen have announced that Ipsen has submitted a Biologics License Application (BLA) to the Food and Drug Administration for the botulinum-toxin product Reloxin to be used in aesthetic indications, news source Prime Newswire reports.
Q & A: Demystifying 529 savings plans
April 1st 2008Yes, a rollover into a different 529 program may be made an unlimited number of times as long as a new beneficiary is named on the account each time. If a rollover is done without changing the beneficiary, no additional rollovers may be completed in the following 12 months unless the beneficiary is changed. In any case, the rollover must be completed within 60 days and you should look into any restrictive terms and charges that may apply.
Unbalanced budget: Medicare reimbursement cut looms in July
April 1st 2008The federal budget for FY 2009, one that provides for $3.1 trillion in federal funding and includes overall Medicare reductions of $196 billion over five years, says about the problem that is the key to continuing Medicare physician reimbursement cuts – the Sustainable Growth Rate (SRG) formula.
Your pharmaceutical rep: How much information can he/she give about off-label use?
April 1st 2008Dr. Doc has an extraordinarily busy dermatology practice. In fact, he is so busy that he has little time to attend medical meetings. He depends on his pharmaceutical representatives to provide him with the latest information about off-label use of various dermatologic prescription drugs. He knows that physician off-label use of prescriptions is not only legal, but is actually encouraged by the Food and Drug Administration (FDA).