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Biovail Corp., Toronto, (905) 286-3000, has received an approvalletter from the FDA for its orally disintegrating tabletformulation of citalopram hydrobromide for the treatment ofdepression. Citalopram ODT, a tablet version of immediate-releasecitalopram HBr, a selective serotonin reuptake inhibitor, isavailable in 10-, 20-, and 40-mg strengths. It offers a choice ofdosage form for patients with difficulty swallowing or those havingno access to water.
Biovail Corp., Toronto, (905) 286-3000, has received an approval letter from the FDA for its orally disintegrating tablet formulation of citalopram hydrobromide for the treatment of depression. Citalopram ODT, a tablet version of immediate-release citalopram HBr, a selective serotonin reuptake inhibitor, is available in 10-, 20-, and 40-mg strengths. It offers a choice of dosage form for patients with difficulty swallowing or those having no access to water.
Iplex (mecasermin rinfabate [rDNA origin] injection), from Insmed Inc., Richmond, (804) 565-3000, has been newly approved by the FDA for the treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (Primary IGFD) or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. Iplex, an orphan drug, has seven years of marketing exclusivity.
Novartis has regulatory approval for a new indication for Femara (letrozole) as a post-surgical treatment for postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting). This use of Femara is said to reduce the risk of breast cancer returning by an additional 21% over treatment with tamoxifen and the risk of the cancer metastasizing to other sites by 27%. The once-a-day aromatase inhibitor is already approved for: extended adjuvant treatment of early breast cancer in postmenopausal women following standard adjuvant tamoxifen therapy; as first-line treatment for postmenopausal women with hormone receptor-positive or receptor-unknown locally advanced or metastatic breast cancer; and for treatment of advanced breast cancer in postmenopausal with disease progression following anti-estrogen therapy. Novartis Pharmaceuticals, with U.S. headquarters in East Hanover, N.J., can be reached at (862) 778-8300.
Depakote ER (divalproex sodium), a once-daily extended-release formulation of Depakote tablets, from Abbott Laboratories, Abbott Park, Ill., (800) 255-5162, has been approved for acute mania with mixed episodes associated with bipolar disorder. The drug was already approved for treating migraine and epilepsy.
A new generic product has been approved for the treatment of epilepsy. From Apotex Corp., Weston, Fla., (800) 706-5575, zonisamide capsules are available in 25-, 50-, and 100-mg strengths in 100-count bottles. The antiseizure medication offers an alternative to Eisai's Zonegran.
American Pharmaceutical Partners has FDA approval for azithromycin for injection, offering a generic alternative to Pfizer's Zithromax. The anti-infective drug, available in 500-mg bottles, is indicated for the treatment of community-acquired pneumonia and pelvic inflammatory disease when caused by susceptible microorganisms.