Upjohn's Caverject Approved In The USA

Upjohn has been granted approval by the US Food and Drug Administration to market Caverject Injection (alprostadil sterile powder) for the diagnosis and treatment of male erectile dysfunction due to neurologic, vascular, psychological or mixed causes. The product is the first prescription medication for erectile dysfunction to be approved in the USA, although other drugs have been used off-label for many years (see also pages 26-27).

The New Drug Application for Caverject was filed in the USA in February 1994. The drug was first approved in the same year by the Swedish Medicines Control Agency (Marketletter February 21, 1994). It is expected that the drug should be available in pharmacies by late August.

Caverject is administered via small needle injection into an area of the penis known as the corpus cavernosum. Upjohn recommends that patients selected for treatment receive initial injections from medically-trained personnel to determine optimum dosing, whereupon Caverject may be self-administered by the patient at will. The maximum dose should not exceed 60mcg, according to the company. It is available in 10mcg and 20mcg vials.