|Class||Name/Company||Approval Dates and Comments|
The US FDA approved this dressing in January 2000, for the management of full-thickness skin injuries. This dressing is provided in single sheets for one-time use only.
An NDA was submitted to the US FDA in December 1999, for this novel topical therapy for the treatment of cutaneous lesions in patients with stage IA, IB, or IIA cutaneous T-cell lymphoma (CTCL) who have not tolerated other therapies or who have refractory or persistent disease. The US FDA granted orphan drug designation for the treatment of patients with CTCL.
An NDA was submitted to the US FDA in October 1999, to gain marketing approval for the treatment of excessive facial hair in women.
An NDA was submitted to the US FDA in November 1999, for this biomaterial and cell culture biotechnology for the treatment of epidermolysis bullosa, Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme. The company is seeking approval to market this product under a Humanitarian Device Exemption, which allows access to devices that can potentially improve patient outcomes for critical diseases or conditions that affect < 4000 people in the US a year.
HPB – Ottawa approved an additional indication for this drug in November 1999. It can now be used for the treatment of recurrent herpes simplex infections (genital herpes and cold sores) in HIV infected patients. It is already available for the treatment of herpes zoster, recurrent genital herpes and the suppression of recurrent genital herpes in patients who are immunocompetent.
The German drug regulatory authorities approved this drug in September 1999, for the treatment of uncomplicated skin and skin structure infections. It has already been approved in the US, the UK and Mexico.
Male Pattern Hair
The UK MCA approved this drug in October 1999, for the new indication of male pattern hair loss. It is currently available in the UK for the treatment of benign prostatic hyperplasia.
HPB – Ottawa issued a drug warning in November 1999, to consumers not to use Miralex Cream (Miralex Healthcare Inc/Hueson Pharmaceutical) because it has been found to contain clobetasol, a prescription corticosteroid that could cause severe adverse reactions if used without medical supervision. Anyone using this product is asked to contact his or her health care provider in order to find an alternative treatment.
Teva USA has issued a Dear Doctor letter in October 1999, regarding labelling changes for Pimozide (Orap) used to treat Tourette’s Syndrome. Labelling will now include warnings about using this drug in combination with clarithromycin and other products that inhibit the CYP 3A enzyme. This follows two sudden unexpected deaths in the past few years linked to the use of this drug at higher than recommended doses and in combination with clarithromycin.
Access Pharmaceuticals began a trial in October 1999, in the UK with its Amlexanox Biodgradable Disc (OraDisc) for the treatment of mouth wounds. This is a polymer disc that adheres to the wound site and slowly erodes, releasing the drug. Amlexanox is already being marketed in the US (Aphthasol) for the treatment of canker sores.