|Class||Name/Company||Approval Dates and Comments|
The US FDA approved this novel foam formulation in May 2000, for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate-to-severe corticosteroid-responsive dermatoses of the scalp.
The European Union’s Committee for Proprietary Medicinal Products recommended marketing approval in July 2000, of this topical treatment for cutaneous lesions from AIDS-related Kaposi’s sarcoma.
The US FDA approved this bi-layered, living skin substitute in June 2000, for expanded use with conventional diabetic foot ulcer care in the treatment of diabetic foot ulcers > 3 weeks in duration.
The US FDA approved this gel in June 2000, for the treatment of cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma who cannot tolerate other therapies.
The US FDA issued an approvable letter in June 2000, for the treatment of oral facial herpes. Docosanol is the first approvable OTC treatment for this disease.
Gensia Sicor Pharmaceuticals
The US FDA tentatively approved Gensia Sicor Pharmaceuticals’ ANDA in June 2000, for the generic injection form of Bristol-Myers Squibb’s bleomycin (Blenoxane). If fully approved, bleomycin will be used alone or in combination with other chemotherapeutic agents for the management of squamous cell carcinoma, lymphomas and testicular carcinoma.
Oncologic Agent Re: M-Vax
M-Vax (AVAX Technologies), an autologous cancer vaccine for melanoma is now commercially available in Australia for Stage III melanoma metastatic to the lymph node.
Anorectal Preparations Re: Rectogesic
Cellegy Pharmaceuticals completed the acquisition of Quay Pharmaceuticals in Australia in June 2000. Quay’s product Rectogesic (nitroglycerin ointment) for the treatment of anal fissures has been on the market for more than a year in Australia.
Oncologic Agent Re: Allovectin 7
Phase II and Phase III trials of Allovectin-7 (Vical, Inc) will continue on the recommendation of Vical’s data safety review board. Phase II studies will evaluate the drug’s efficacy in metastatic, refractory stage III or IV melanoma that has not spread to multiple organs. Phase III studies will evaluate this drug with standard chemotherapy in patients with unresectable, metastatic melanoma not previously treated with chemotherapy.
HIV/AIDS Re: Drug pricing
In an attempt to provide greater access to HIV/AIDS treatment, five pharmaceutical companies will reduce the prices of their drugs to treat HIV and AIDS associated illnesses for South Africa and other developing countries. Participating companies include: Boehringer Ingelhelm, F. Hoffman-La Roche, Glaxo Wellcome, Bristol-Myers Squibb, and Merck . The companies are working in cooperation with the United Nations.
Oncologic Agent Re: Maxamine
The University of Pittsburgh Cancer Institute has reported that the immunomodulating agent Maxamine (histamine dihydrochloride), used in combination with interleukin-2 (IL-2), improved survival for stage IV malignant melanoma patients when compared to those treated with IL-2 alone. Preliminary results also indicated that treatment with Maxamine and IL-2 was safe and well tolerated and had substantially less toxicity than the high-dose regimens of IL-2.
Urticaria Re: Allegra
In June 2000 Aventis Pharmaceuticals announced that Allegra (fexofenadine HCl) 30mg tablets are now available by prescription for the relief of seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 6-11 years. The US FDA approved Allegra for this additional indication in February 2000.