BioMarin Pharmaceutical, Novato, Calif., (415) 884-6700, has gainedFDA approval for Naglazyme (galsulfase), the first specifictreatment for mucopolysaccharidosis VI (MPS VI), suffered byapproximately 1,100 persons in the developed world. Granted orphandrug status in the United States, Naglazyme will have seven yearsof market exclusivity. MPS VI is a serious and debilitatingdisease, and most of those afflicted die from its complicationsbetween childhood and early adulthood.
NEW DRUGS BioMarin Pharmaceutical, Novato, Calif., (415) 884-6700, has gained FDA approval for Naglazyme (galsulfase), the first specific treatment for mucopolysaccharidosis VI (MPS VI), suffered by approximately 1,100 persons in the developed world. Granted orphan drug status in the United States, Naglazyme will have seven years of market exclusivity. MPS VI is a serious and debilitating disease, and most of those afflicted die from its complications between childhood and early adulthood.
There is a newly approved single booster immunization against pertussis, tetanus, and diphtheria for patients aged 11 to 64. Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed), from Aventis Pasteur Ltd., Toronto, (416) 667-2701, is the first vaccine approved as a pertussis booster for adults.
NEW INDICATIONS Amgen Inc., Thousand Oaks, Calif., and Wyeth Pharmaceuticals, Collegeville, Pa., have announced an expanded indication for Enbrel (etanercept) to improve physical function in patients with psoriatic arthritis. Labeling will also be updated to include new data demonstrating that the drug continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients receiving ongoing therapy. Enbrel was approved earlier for treating the signs and symptoms of psoriatic arthritis, moderate to severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. For further information, contact Amgen at (888) 436-2735.
NOW AVAILABLE For patients with mild to moderate Alzheimer's disease-especially those who have difficulty swallowing tablets-a new formulation of Aricept (donepezil HCl) is now available. Approved late last year, Aricept ODT disintegrates almost immediately in the mouth but should be followed by a drink of water. It is available in 5-mg and 10-mg tablets in blister packaging, delivering the same dosage strength as Aricept tablets. The drug will be co-promoted by Eisai Inc., Teaneck, N.J., (201) 692-1100, and Pfizer Inc., New York City, (212) 733-2323.
Approved late last year, Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol is now available from Boehringer Ingelheim, Ridgefield, Conn., (203) 798-9988. The hydrofluoroalkane version of Atrovent was formulated to provide a non-chlorofluorocarbon (CFC) propellant for the bronchodilator. The product is indicated for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema, but is not indicated for rescue use.
Now available nationwide from Ortho-McNeil Neurologics, Titusville, N.J., is Razadyne ER (galantamine hydrobromide), approved in December 2004. Razadyne capsules offer a once-daily treatment for the symptoms of mild to moderate Alzheimer's disease. Galantamine hydrobromide was approved in 2001 as the twice-daily medication Reminyl; the product name was changed in April 2005. For further information, contact Ortho-McNeil Pharmaceuticals, Raritan, N.J., (800) 682-6532.
REINTRODUCTIONS AR Scientific, an affiliate of United Research Laboratories/Mutual Pharmaceutical Co., Philadelphia, is launching Bactrim (sulfamethoxazole 400 mg and trimethoprim 80 mg) and Bactrim DS Tablets (sulfamethoxazole 800 mg and trimethoprim 160 mg [double strength]), introduced earlier by Hoffmann-La Roche. The antibacterial agents are indicated for the treatment of urinary tract infections, acute otitis media, acute exacerbations of chronic bronchitis, shigellosis, Pneumocystis carinii pneumonia, and traveler's diarrhea in aduts. For further information, call (215) 807-1045.