FDA Approves drug delivery system for Watson Pharmaceutical's TRELSTAR DEPOT and TRELSTAR LA
Dated: 5/12/2008
Watson Pharmaceuticals, Inc. announced that the US Food and Drug Administration has approved MIXJECT, the new delivery system for TRELSTAR (triptorelin pamoate for injectable suspension), a palliative treatment for advanced prostate cancer.
MIXJECT, developed and manufactured by Medimop Medical Projects Ltd. a subsidiary of West Pharmaceutical Services, Inc., combines the proven efficacy of TRELSTAR DEPOT 3.75 mg and TRELSTAR LA 11.25 mg with new features that make preparation, administration and disposal easier.
These new features include: a smaller 21-gauge needle for improved patient comfort; reconstitution without the use of a needle; and a shield covering the needle both before and after drug administration.
The system is specifically designed to encourage compliance with OSHA (Occupational Safety and Health Administration) regulations within the medical community.
Prostate cancer is the most common cancer in men in the US, excluding skin cancer, and is estimated to account for 25% of all new cancers diagnosed in men.
According to the American Cancer Society, approximately 186,320 new cases of prostate cancer are expected to be diagnosed in 2008 in the US; 28,660 men with prostate cancer are expected to die this year.
The majority of cases diagnosed are in men over the age of 65.
