|Class||Name/Company||Approval Dates and Comments|
Anesthetic – topical
Emla® patches, previously approved by the FDA, are now launched in the US for the reduction of pain associated with injections in children aged over one month.
Psoriasis – severe recalcitrant plaque
Approved by the US FDA in October, 1998, SangCya® is the first generic formulation of cyclosporin to reach the market. Like Neoral®, it is approved for use in adult, non-immunocompromised patients who have failed to respond to at least one other systemic therapy.
Lotion dosage form was approved by the US FDA November, 1998 for the treatment of the inflammatory papules and pustules of rosacea.
Warts – External genital & perianal
Aldara® is now available in the UK (its first European market), following approval by the UK Regulatory Agency in late 1998. It is already available in the US, Australia and New Zealand.
Approved by the US FDA for closing lacerations and incisions that otherwise would require sutures, staples or skin strips.
Aids-related Kaposi’s sarcoma
The FDA has issued Ligand Pharmaceuticals with a letter stating that Panretin® is approvable for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma.
Schering-Plough is taking action against Pfizer and UCB Pharma for the alleged breach of a 1996 settlement relating to marketing claims for cetirizine. Schering-Plough can claim that loratidine is non-sedating. Cetirizine’s labelling includes a warning about drowsiness, but Schering-Plough allege that Pfizer and UCB are promoting the drug as being non-sedating and less sedating than loratidine. (Scrip 2378, October 14, 1998)
A joint meeting of the US FDA’s Non-prescription Drugs and Antiviral Drugs Advisory Committees (NDAC and ADAC) voted against Denavir® being switched from prescription only to OTC.
Awaiting approval by the FDA. Results from a pivotal study show that this vaccine is as effective in a six-month dosing schedule as in a 12-month schedule.