Class | Name/Company | Approval Dates and Comments |
Anesthetic – topical |
Astra | 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 |
Sangstat | 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. |
Rosacea |
Galderma | 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 |
3M Pharmaceuticals | 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. |
Wound closure |
| Approved by the US FDA for closing lacerations and incisions that otherwise would require sutures, staples or skin strips. |
Drug News | ||
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. |
Antihistamines |
| 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) |
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Herpes labialis |
| 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. |
Lyme disease |
| 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. |