|Approval Dates and Comments
Advanced Polymer Systems and Dermik Laboratories
The US gave marketing approval in October 2000, for this formulation to treat actinic keratoses. Microsponge is a system of porous polymer microspheres loaded with an active ingredient and dispersed in a cream for topical application.
The US FDA granted orphan drug designation in October 2000, for this self-disintegrating tablet to treat papillomavirus warts in the oral cavitiy of HIV positive patients.
The US FDA approved this generic formulation 1000mg tablet in October 2000, for use in the treatment of melanoma.
The European Union’s Committee for Proprietary Medicinal Products approved this HIV protease inhibitor (PI) in October 2000, to be used in combination with other anti-retroviral agents for the treatment of PI-experienced HIV infected adults and children > 4 years of age.
The US FDA approved this topical gel in October 2000, for the treatment of actinic keratosis. Solaraze is currently approved in five member states of the EU (France, Germany, Italy, Sweden and UK) as well as in Canada.
Because of the similarity between the brand names Lamictal (lamotrigine) and Lamisil (terbinafine), Glaxo Wellcome cautioned health professionals, especially pharmacists, to be aware of the potential for a dispensing error. They also encouraged clinicians to review the indications, appearance and dosages of both products to avoid medication errors.
The American College of Foot and Ankle Surgeons (ACFAS) announced new clinical practice guidelines in October 2000 issue of The Journal of Foot and Ankle Surgery, for the diagnosis and treatment of diabetic foot disorders. These new guidelines appear as a supplement and are intended for any medical specialist who treats diabetic patients.
The Florida Tumor Registry in the US indicates that clinicians should give special attention to men, people who are not married, smokers, and those who are less educated and not as aware of melanomas, even when they present with other medical problems. These assessments should be added to known melanoma risk factors such as a family history of melanoma and excessive exposure to the sun.
According to data released by IMS Health, Canadian doctors are prescribing less antibiotics. By the end of 1999, 25.5 million prescriptions had been written compared to 27.3 million in 1995. The 1999 numbers work out to 0.8 prescriptions per capita, which is lower than in the US where the average is one antibiotic prescription per capita.
Phase III studies show that Genelabs Technologies’ investigational drug, Aslera (GL 701 or prasterone) significantly improves disease activity and symptoms of patients with systemic lupus erythematousus. A NDA was submitted to the US FDA in September 2000, and granted priority review designation in October 2000.