|Class||Name/Company||Approval Dates and Comments|
The US FDA approved this lower dose formulation in May 2002, for the treatment of acne. This product is formulated with A.P Pharma’s Microsponge® technology
The US FDA approved this generic immunosuppressant in May 2002. It is the generic equivalent of Novartis Pharmaceuticals’ Sandimmune®.
The US FDA approved this anticonvulsant agent in May 2002, for the management of post-herpetic neuralgia, or pain in the area affected by herpes zoster after the disease has been treated. Neurontin® is also indicated as an add-on treatment for partial epileptic seizures.
Avanir Pharmaceuticals/ GlaxoSmithKline
The Korea Food and Drug Administration approved this cream in May 2002, as an OTC topical treatment for cold sores. Also in May, TPP Canada approved this product for marketing and an NDA was submitted to the Swedish regulatory authorities seeking marketing approval there. In the US and Canada it is known as Abreva®.
The Swedish Medical Products Agency approved this product in June 2002, for the treatment and removal of warts.
Connetics Corporation announced in May 2002, that it licensed exclusive rights to develop and commercialize Velac® gel (clindamycin 1% and tretinoin 0.025%) in the US and Canada, and has licensed non-exclusive rights in Mexico. Connetics plans to request a pre-IND meeting with US FDA officials. Pending the outcome of that meeting, current plans are to begin clinical trials early in 2003. Under the current development timeline, Connetics expects to file an NDA for this product with the US FDA during the second half of 2004.
DUSA® announced in June 2002, that its marketing and development partner for Levulan® PDT (Schering AG, Germany and its US affiliate Berlex Laboratories) has served a notice of termination in accordance with the parties’ marketing, development and supply agreement. As a result, DUSA® will be reacquiring all rights granted under the agreement by the end of June 2003. These include product marketing, reimbursement, inventory management and distribution and regulatory compliance. During the 12-month transition period Berlex will continue to sell the Kerastick™. Levulan® PDT is currently indicated for the treatment of actinic keratoses of the face and scalp.
Trichotillomania is a chronic psychiatric disorder that is sometimes difficult to diagnose. According to an article recently published in the Journal of Cutaneous Pathology*, researchers evaluated 28 scalp biopsies from 26 patients revealed trichomalacia in 57% and pigmented casts in 46%. They suggest that together with clinical suspicion of trichotillomaina, trichomalacia and pigmented casts are major criteria when coming to a diagnosis.