|Class||Name/Company||Approval Dates and Comments|
Pharmacia and Upjohn
The US FDA approved this drug in January 2000, for the treatment of urogenital symptoms associated with post-menopausal vaginal atrophy.
The US FDA approved this drug in February 2000, for the additional treatment of uncomplicated skin manfestations of chronic idiopathic urticaria in adults and children ≥ 6 years of age
The US FDA approved this emulsion/aerosol foam in March 2000, for the treatment of head, pubic (crab), and body lice.
An NDA was submitted to the US FDA in October 1999, for this photodynamic therapy product. Also in October 1999, Scotia filed this product for centralized approval in the EU for head and neck cancer. The Netherlands will act as rapporteur and Denmark as co-rapporteur.
Dear Doctor Letter
Lederle Pharmaceuticals issued a Dear Doctor letter in November 1999, regarding labelling changes for methotrexate products. Revised labelling warns that rare reports of bone and soft tissue necrosis have occurred following radiation therapy in patients receiving this drug. There have also been rare reports of painful plaque erosions when methotrexate was used to treat psoriasis. The drug interactions section now recommends that patients who receive this drug with potentially hepatotoxic agents be closely monitored for possible increased risk of hepatotoxicity. The Overdosage section notes that routine hemodialysis and hemoperfusion are ineffective in lowering methotrexate blood levels and corrective measures may include high-flux dialysis equipment.
Aristolochic acid, a known nephrotoxin present in Chinese herbs known as MuTong, has been identified as the cause of renal failure in two women who were taking the drugs for excema, according the a report in the November 1999 issue of the Dermatology Times. As a result, this drug has been banned in the UK and a drug warning was issued by HPB – Ottawa. The kidney disease suffered by these two patients is a progressive fibrosis that leads to end-stage renal failure. Both patients had been taking the drug for more than 2 years. It is not known how long it takes the herb to cause kidney problems. MuTong refers to a number of herbs including Stephania, Clematis, Akebia and Aristolochia, which are used interchangeably in traditional Chinese medicines.
The US FDA announced in March 2000, that Clinipad Corp. of Rocky Hill, Connecticut in the US is voluntarily recalling their antiseptic sterile skin preparations because of a potential for bacterial contamination. The products are distributed under the names: Clinipad, Clinidine, Cliniguard, EX Prep, Cooper Instrument Corp., Moore Medical Corp., and Rausher. They are used to control and prevent infection.
According to Dr. John Goldsmith of New Zealand in an internet release from Medsafe, the dosage recommendations for lidocaine-prilocaine (EMLA) cream should be followed carefully and the cream should be used with care in infants up to 12 months of age. Adverse effects, particularly methaemoglobinaemia, can occur in this age group.
Avanir Pharmaceuticals signed a letter of intent in December 1999, with SmithKline Beecham for rights to market Avanir’s Docosonol 10% cream in the OTC market as a treatment for recurrent oral-facial herpes or cold sores. Docosanol’s FDA approval as an OTC product is pending.