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First Estradiol Transdermal Spray

Vivus, Inc, received FDA approval for their estradiol metered dose transdermal spray (Evamist) for the treatment of moderate-to-severe vasomotor symptoms in the menopausal woman. The small, hand-held, quick-drying estradiol spray is administered once daily and allows the patient to receive a preset dose of estradiol via the skin with ease and convenience. In a phase 3 clinical trial involving 454 menopausal women, the transdermal spray decreased the number of vasomotor symptoms per day by 78%. KV Pharmaceutical Company has been licensed the US marketing rights and plans to launch the new drug in the latter half of the 2008 fiscal year.

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Molecular-Based Lab Test for Breast Cancer

Johnson & Johnson Company received FDA approval for the first molecular-based laboratory test (GeneSearch BLN Assay) indicated for the detection of metastatic breast cancer in nearby lymph nodes. Able to rapidly detect the presence of cancer cells in the sentinel node shortly after a lumpectomy or mastectomy, the novel breast cancer test shortens the delay of treatment time or reduces the need for a second surgery by offering results while the patient is still in the operating room. In a clinical trial examining the lymph nodes of 416 cancer patients the molecular test successfully predicted cancer progression in 88% of patients with metastatic breast cancer and was 94% accurate in detecting nonmetastatic breast cancer.

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First CCR5 Antagonist Approval for HIV

The FDA granted accelerated approval for Pfizer Inc’s maraviroc (Selzentry) oral tablets indicated for the treatment of chemokine receptor 5 (CCR5)-tropic human immunodeficiency virus (HIV)-1 for patients unresponsive to standard forms of antiretroviral treatment and who show evidence of viral replication. The first-in-class CCR5 antagonist inhibits viral entry into T-cells by blocking the CCR5 co-receptor. Accelerated approval was based on 24 weeks of ongoing, double-blind, clinical trials of HIV patients. Pfizer plans to conduct further clinical trials to obtain traditional FDA-approval.

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Artificial Cervical Neck Disc

Medtronic Sofamor Danek received FDA approval for their artificial cervical disc (Prestige Cervical Disc) for the treatment of cervical degenerative disc disease. The stainless steel, two-piece artificial disc is inserted into the cervical spine with bone screws, replacing the diseased degenerative disc. Results from a clinical trial examining the disc’s safety and efficacy in 541 patients showed a decrease in both neck and arm pain among trial participants. As a condition of approval, Medtronic Sofamor Danek must conduct a 7-year follow-up study evaluating the device’s long-term effects.

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Limited Approval for IBS-C and CIC Treatment

The FDA recently announced that it granted approval for an investigational new drug protocol for Novartis’ tegaserod (Zelnorm), permitting its use for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than age 55 years and who present with no pre-existing heart complications. Originally approved in 2002 for the short-term treatment of IBS in women and in 2004 for the treatment of CIC, the drug was recalled from the market in March, 2007, after a safety analysis revealed an increased risk of heart attack, stroke, and unstable angina compared to placebo. The treatment is administered only when medically necessary to patients that meet the specific age, gender, and medical history criteria.

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New Generics for Onychomycosis

In a continuing effort to increase the availability of low-cost drugs to the public, the FDA recently approved the first generic versions of Novartis AG’s prescription terbinafine (Lamisil) indicated for the treatment of toenail and fingernail onychomycosis. Approval for terbinafine 250-mg tablets was granted to several generic drug manufacturers. The FDA also approved a generic version of Taro Pharmaceuticals Inc’s over-the-counter terbinafine hydrochloride cream, 1%, for the treatment of onychomycosis.

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