|Approval Dates and Comments
The Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) recommended approval in May 2001, of the 5mg tablets of this nonsedating antihistamine for the treatment of the symptoms of chronic idiopathic urticaria.
The US FDA granted marketing approval in May 2001, for the topical treatment of mild to moderate inflammatory acne. Finevin® will be the second azelaic acid product available on the US market.
The US FDA approved this drug in May 2001, for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients.
An NDA was submitted to the US FDA in May 2001, for this potent antibiotic that is coupled with Atrix’s proprietary drug delivery system, SMP®. This special system allows water insoluble drugs to be applied topically. Atrisone® is currently in a pivotal Phase III clinical trial for treatment of moderate to severe acne, and in Phase I proof of concept trials for treatment of itch associated with healing severe burn wounds.
The US FDA issued a Public Health Advisory in May 2001, to announce labeling changes for Sporanox® (Itraconazole, Janssen Phramaceutica). These changes include a warning to physicians not to prescribe Sporanox® capsules to treat onychomycosis in patients who have a history of heart failure, including congestive heart failure (CHF). It further states that Tikosyn® (Dofetilide, Pfizer) an antiarrhythmic agent should not be taken in conjunction with itraconazole, and caution should be used when co-administering Sporanox® with calcium channel blockers. The antibiotic erythromycin was also added to the list of drugs that interact with Sporanox®.
The US FDA issued a Public Health Advisory in May 2001, to alert healthcare professionals that rare cases of serious liver problems have been associated with Sporanox® capsules (Itraconazole, Janssen Phramaceutica) and Lamisil® tablets (Terbinafine HCl, Novartis Pharmaceuticals). The new labeling recommends that that clinicians should obtain nail specimens for laboratory testing prior to prescribing either of these drugs for fungal nail infections. FDA concerns do not apply to topical Lamisil® products.
Two lots (#0000067143 and 0000067144) of a collegenase product (Santyl® Ointment, Abbott Laboratories) were recalled because these lots were found to exceed potency limits. This ointment is indicated for the treatment of debriding chronic dermal ulcers and severely burned areas.
The World Health Organization (WHO) announced in May 2001, that the global prevalence of leprosy has been reduced by over 90% over the past 10 years. However, six countries, including Brazil, India, Madagascar, Mozambique, Myanmar, and Nepal still report elevated rates of this disease because leprosy services were not available in the more remote areas.