New product newswire

RX

NEW DRUGS

The FDA has approved Ionsys (fentanyl iontophoretic transdermal system) for short-term management of acute postoperative pain in adults requiring opioid analgesia during hospitalization. The transdermal narcotic is the product of Alza Corp., Mountain View, Calif., (650) 564-5000.

Thalidomide, marketed as Thalomid by Celgene Corp., Summit, N.J., (908) 673-9000, has received FDA approval for a new indication and can now be used to treat newly diagnosed multiple myeloma. Thalomid was previously approved for the treatment of leprosy.

For Cubist Pharmaceuticals, Lexington, Mass., (781) 860-8660, the FDA has approved a new indication for Cubicin (daptomycin for injection). The drug can now be used as a once-a-day treatment (at 6 mg/kg) for Staphylococcus aureus bloodstream infections. Cubicin was already approved for the treatment of complicated skin and skin structure infections.

Centocor Inc., Horsham, Pa., (610) 651-6000, has received approval for a new indication for Remicade (infliximab). The drug can now be used to treat children with active Crohn's disease. The monoclonal antibody, which reduces inflammation, was previously approved for treating Crohn's disease in adults.

NEW GENERICS

FDA approval has been given to Watson Pharmaceuticals, Corona, Calif., (951) 493-5300, for a generic version of Berlex' oral contraceptive Levlite. Levonorgestrel/ethinylestradioltabletsUSP are available in 0.1/0.02 mg for the prevention of pregnancy.

An extended-spectrum semisynthetic cephalosporin has been approved for Lupin Pharmaceuticals, Baltimore, (410) 576-2000. Cefdinir capsules, 300 mg, a generic equivalent of Abbott's OmnicefCapsules, are indicated to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.

The FDA has approved a generic version of Forest Laboratories' antidepressant Lexapro. Escitalopramoxalate will be available in 5-, 10-, and 20-mg doses. The generic selective serotonin reuptake inhibitor is the product of Ivax Pharmaceuticals, Miami, (305) 575-6000.