Magazine article Drug Topics

New Product Newswire

Magazine article Drug Topics

New Product Newswire

Article excerpt



For the ophthalmology market, Baxter Healthcare, Deerfield, Ill., (847) 948-2000, has approval for Hylenex recombinant (hyaluronidase human injection), used to enhance the absorption and dispersion of other injected drugs. It is available in 2-ml single-dose vials containing 150 units of hyaluronidase per mL. Clinical trials are ongoing to evaluate Hylenex in various hospice and palliative care settings as well as for pediatric indications.

Indevus Pharmaceuticals, Lexington, Mass., (781) 861-8444, is introducing the Supprelln LA (histrelin acetate) subcutaneous implant, 50 mg. Approval is based on its indication for the treatment of central precocious puberty.


CSL Behring, King of Prussia, Pa., (610) 878-4000, has a newly approved indication for Humate-P (antihemophilic factor/vonWillebrand [vWD] factor complex). Originally approved for use in treating and preventing bleeding in hemophilia A in adults, the drug can now be used for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe vWD.

Oscient Pharmaceuticals, Waltham, Mass., (781) 398-2300, has been granted approval for Factive (gemifloxacin mesylate) Tablets for a five-day treatment of mild to moderate community-acquired pneumonia. The five-day treatment with Factive Tablets was approved originally for treatment of acute bacterial exacerbations of chronic bronchitis.

Cincinnati-based Duramed Pharmaceuticals, (513) 731-9900, has approval for a new indication for Enjmria (synthetic conjugated estrogens, B). The product can now be used to treat moderate to severe vaginal dryness and pain with intercourse, symptoms associated with menopause. Enjuvia was approved earlier for treating moderate to severe vasomotor symptoms associated with menopause.


Duramed Pharmaceuticals has added a 0.9-mg tablet to its Enjuvia product line, indicated for treating menopausal symptoms of vaginal dryness and pain. Other available dosage strengths of the medication include 0.3, 0.45,0.625, and 1.25 mg.


For Amgen Inc., Thousand Oaks, Calif., (888) 436-2735, Enbrel (etanercept) 25 mg/0.5 mL prefilled syringe has been approved for single-use dosing. This brings to four the number of delivery options available to treat patients with rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis. …

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