Bertek Pharmaceuticals, a branded-drug subsidiary of Mylan Laboratories, has received approval from the FDA for Apokyn (apomorphine hydrochloride injection) as the first therapy in the United States for the acute, intermittent treatment of hypomobility, or “off” episodes associated with advanced Parkinson’s disease.
Merck & Co. has announced that the FDA approved changes to the prescribing information for Proscar (finasteride) based on a study from the National Institutes of Health. Proscar, administered in combination with the alpha-blocker doxazosin, is now indicated to reduce the risk of the symptoms of benign prostatic hyperplasia (BPH), or benign enlargement of the prostate, from progressing over time.
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Wyeth Pharmaceuticals has received FDA approval for the reformulation of the stomach acid suppressant Protonix I.V. (pantoprazole sodium) for injection. The reformulation eliminates the need for an in-line filter, a previously required extra step in an already time-sensitive procedure to administer the medication to those patients who require immediate acid suppression.
The FDA has sent 3 M an approvable letter for its Aldara (imiquimod) cream as a treatment for superficial basal cell carcinoma, but the agency has requested additional safety data on the drug. 3M reportedly hoped to market this new indication by mid-year, but that plan may be delayed until the second half. Aldara was first approved in 1997 for the treatment of genital warts. 3M has estimated that this additional FDA approval would add $200 million in sales.
Aventis has received FDA approval for Apidra (insulin glulisine [rDNA origin] injection), a rapid-acting insulin analogue, for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.
Medicis and BioMarin Pharmaceutical have entered into an asset purchase and licensing agreement that grants BioMarin exclusive worldwide rights to Orapred (prednisolone sodium phosphate).
Alcon has received FDA approval to add a supplemental list of susceptible pathogens to its Vigamox ophthalmic solution in vitro labeling. zanaflex. The addition of these pathogens demonstrates the breadth of coverage and potency that has made Vigamox the most widely prescribed ophthalmic fluoroquinolone on the market today, the company said. Vigamox solution will now have an additional 22 pathogens added to the in-vitro efficacy section of its package insert, including atypical mycobacteria.
Medlmmune and Wyeth have ended their collaboration for the nasal flu vaccine FluMist as well as the investigational second-generation liquid formulation, known as Cold Adapted Influenza Vaccine-Trivalent or CAIV-T. Medlmmune now will have worldwide rights to these products and will assume full responsibility for the manufacturing, marketing and selling of FluMist.
Bone Care International has received FDA approved of a new indication and strength for Hectorol (doxercalciferol) capsules. Hectorol, a novel pro-hormone vitamin D2 analog, is now approved for the treatment of secondary hyperparathyroidism (SHPT) that develops in the earlier stages (stages 3 and 4) of chronic kidney disease prior to dialysis. It was previously approved for the treatment of SHPT in dialysis patients in the United States.
Copyright CPS Communications Jun 2004
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