In early October, 2006, the drug Zolinza was approved by the FDA to treat CTCL (cutaneous T-cell lymphoma), a rare form of skin cancer.
Zolinza is permitted for use if the disease gets worse, persists, or recurs after treatment with other skin cancer medications. CTCL impacts about 3 in 1 million Americans per year, and was thus approved under the FDA’s Orphan Drug Program, which offer companies incentives for treating diseases which affect fewer than 200,000 Americans each year.
Zolinza is manufactured by Pantheon, Inc., for the drug giant Merck & Co.
The drug is not recommended for pregnant women, as animal studies indicate it could cause fetal harm.
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If you’ve been following the newest trends in skin care, you’ve probably heard of a new term: nanotechnology.
Nanotechnology is a new buzzword in skin care and the cosmetics industry; it refers to the use of very small molecules to help deliver treatments below the skin’s surface.
The biggest complaints about nano-molecules is that they behave differently than their normal-sized counterparts.
This may have adverse reactions for the skin or the environment. For example, one type of nano-particle conducts electricity at nano-size, but does not conduct electricity at full-size.
If this particle were added to cosmetics or skin care products, it may have damaging effects for the individual applying it.
Since many cosmetics and supplements can be sold without FDA approval, this may become a growing issue as nanotechnology allows chemicals to be delivered deeper and deeper into our bodies.
The FDA has created a special group to focus on nanotechnology. We’ll be hearing more about this issue as the science continues to evolve.
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A new breakthrough in treatment of fungal infections came this week as the FDA approved Noxafil (posaconazole) for the prevention of infections caused by certain molds and yeast-like fungus such as Aspergillus and Candida.
The FDA approved the antifungal drug for use in those patients with weakened immune systems (such as following a bone marrow transplant) and for those patients with decreased white blood cell counts (such as follows chemotherapy for cancer).
Healthy individuals are usually unaffected by these common fungi; but people with weak or abnormal immune systems are likely to become fatally ill when exposed to these pathogens.
Noxafil is an antifungal drug which contains an active substance never before approved in the U.S.
Safety and efficacy of Noxafil were tested in clinical trials of 1,844 patients ranging in age from 13-82 years.
Patients who received Noxafil had comparable or fewer rates of Aspergillus and Candida infections compared to those who received other antifungal medications.
The most common side effects of Noxafil were nausea, vomiting, rash, diarrhea, lowered potassium (K+) blood levels, lowered platelet counts, and abnormal results on tests of live function. For some people, Noxafil may have led to abnormal heart rhythm (prolongation of the QTc wave) and liver function impairement.
Noxafil should be taken with a full meal, and has been shown to interact severely with certain other medications.
Noxafil offers a new option for antifungal treatment following bone marrow transplant or chemotherapy.
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