New product newswire

October 24, 2005

Carrying the first new therapeutic mechanism of action in 35 years, according to manufacturer Takeda Pharmaceuticals, Rozerem (ramelteon) 8-mg tablets are now available for the treatment of insomnia characterized by difficulty with sleep onset.

RX

NEW DRUGS

Carrying the first new therapeutic mechanism of action in 35 years, according to manufacturer Takeda Pharmaceuticals, Rozerem (ramelteon) 8-mg tablets are now available for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem shows no clinical evidence of abuse or dependence; thus, the drug is not classified as a controlled substance and can be used long-term. Takeda is in Lincolnshire, Ill., at (847) 383-3000.

NEW INDICATIONS

New indications have been granted for two Pfizer medications. The COX-2 inhibitor Celebrex (celecoxib) can now be used to relieve the signs and symptoms associated with ankylosing spondylitis. Celebrex was approved earlier for treating patients with osteoarthritis and adult rheumatoid arthritis, acute menstrual pain, and familial adenomatous polyposis. The lipid-lowering agent Lipitor (atorvastatin calcium) can now be used to reduce the risk of stroke and heart attack in patients with Type 2 diabetes without evidence of heart disease but with other risk factors. It has also received approval for reducing the risk of stroke in people without evidence of heart disease but with multiple risk factors other than diabetes.

Merck & Co.'s VAQTA (hepatitis A vaccine, inactivated) can now be used in children as young as one year of age. Previously approved for use in patients aged two years and older, VAQTA is indicated for active immunization against disease caused by hepatitis. Merck, Whitehouse Station, N.J., can be reached at (908) 423-1000 ... Also for Merck, Singulair (montelukast sodium) is now indicated for once-a-day relief of the symptoms of perennial allergic rhinitis in adults and children six months of age and older. Singulair is available in 10-mg tablets for adults, in 4- or 5-mg chewable tablets for children aged two to 14 years, and in oral granules (4 mg) for children six months to five years of age.

NEW GENERICS

Danazol capsules have been approved for Pheladelphia-based Lannett Co., (215) 33309000. Danazol, a gonadotropin inhibitor and sex hormone, is generic version of Sanofi-synthelabo's Danocrine. Danazol is used for treating endomedrisis and fibrocystic breast disease and for the prevention of angioedema.

Barr Laboratories, Woodcliff Lake, N.J., (800) 222-0190, and Kali Laboratories, Somerset, N.J., (732) 537-0400, have approval for clonazepam orally disintegrating tablets, 0.125, 0.25, 0.5, 1, and 2 mg. Used alone or as an adjunct in the treatment of Lennox-Gastaut syndrome, akinetic and myoclonic seizures, and panic disorder (with or without agoraphobia), the product offers a generic equivalent to Roche's Klonopin Wafers.

Pamidronate disodium injection, Sicor Pharmaceuticals, Irvine, Calif., (800) 729-9991, is approved as alternate therapy to Novartis' Aredia for Intravenous Infusion. The bone-resorption inhibitor treats Paget's disease, hypercalcemia of malignancy, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.