New product newswire: May 7, 2007

May 7, 2007

Rxs, generics, OTCs, home healthcare items

RX

NEW DRUGS

Baxter Healthcare, Deerfield, Ill., (847) 948-2000, has received FDA approval for Ceprotin (protein C concentrate [human]), indicated as replacement therapy in pediatric and adult patients with life-threatening blood-clotting complications associated with severe congenital protein C deficiency. Although a rare condition, this deficiency implies an abnormal tendency toward blood clotting, and the biologic has been granted orphan status for the prevention and treatment of venous thrombosis and purpura fulminans.

Rhophylac Rh (immune globulin intravenous [human]) has received FDA marketing approval for an additional indication. Rhophylac, an anti-D Rh immunoglobulin from CSL Behring, King of Prussia, Pa., (610) 878-4000, can now be used for treating immune thrombocytopenic purpura (ITP). The drug is administered intravenously to raise platelet counts in Rh(0) (D)-positive non-splenectomized adult patients with chronic ITP.

Winnipeg, Canada-based Cangene Corp. has received approval for HepaGam B for the prevention of hepatitis B reinfection in liver transplant patients with a prior history of the disease. According to the company, it is the first immune globulin product approved for this indication. HepaGam B was FDA-licensed last year to prevent infection with hepatitis B virus in patients with prior exposure to HBV. The company can be reached at (204) 275-4178.

NEW FORMULATIONS

With a U.S. base in Baltimore, Lupin Pharmaceuticals, (410) 576-2000, is bringing out a higher-concentration formulation of its existing Suprax anti-infective. Suprax (cefixime for oral suspension 200 mg/5 ml) allows fewer teaspoonfuls per dose than the existing 100 mg/5 ml suspension.

NEW DOSING

GlaxoSmithKline, headquartered in Philadelphia at (888) 825-5249, has announced an accelerated dosing schedule for Twinrix (hepatitis A vaccine [inactivated] and hepatitis B [recombinant] vaccine). The drug is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was originally approved for adults over 18 years of age on a 0-, 1-, 6-month dosing schedule.

Risperdal Consta (risperidone) Long-acting Injection, a product of Janssen Pharmaceutica, has a newly approved 12.5-mg dose for use in the treatment of schizophrenia. The new dosage strength will enable physicians to better customize and adjust treatments. Janssen, with offices in Titusville, N.J., can be reached at (800) 523-6225.

NEW DOSAGE FORM

PRODUCT ENHANCEMENTS

Wyeth Pharmaceuticals, Collegeville, Pa., (610) 902-1200, is providing enhancements to BeneFIX (coagulation factor IV [recombinant]), offering hemophilia B patients more convenience in product preparation. BeneFIX replaces clotting factor IX to stop or prevent bleeding in hemophilia B patients lacking sufficient factor IX of their own. Patients using the 1000-IU dosage strength can now use a lower volume of diluent to administer the product, and a new needleless preparation process eliminates the risk of needlestick injury during reconstitution.

NEW PACKAGING