PHARMACY

Marsh implements generic drug pricing offer

BY Michael Johnsen

INDIANAPOLIS — Marsh Supermarkets recently implemented a $3.99/$9.99 generic drug pricing offer for 30-day and 90-day prescriptions, respectively.

The program applies to a designated list of generic drugs at commonly prescribed dosages (higher dosages cost more).

And it’s not the only pharmacy-oriented program being offered across many of the company’s 41 pharmacies. Marsh also is the exclusive supermarket supporting Project 18, a grassroots campaign to tackle childhood obesity. Developed by Peyton Manning Children’s Hospital at St. Vincent, Ball State University and Marsh Supermarkets, the program provides better eating choices and nutritional information for kids.

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PHARMACY

FDA approves Watson oral contraceptive

BY Antoinette Alexander

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson’s new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

"The approval of this oral contraceptive further strengthens Watson’s robust and expanding branded Women’s Health portfolio," stated Fred Wilkinson, EVP global brands. "We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women."

The contraceptive product, licensed from a subsidiary of Warner Chilcott, will actively be marketed to physicians by Watson’s Global Brands division beginning in second quarter 2011.

The approval of the oral contraceptive is based on data from a 12-month, phase-3, multicenter, open-label study that evaluated the safety and efficacy of the product for pregnancy prevention. Among 1,251 women between the ages of 18 and 35 years who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) was 2.01 pregnancies per 100 women-years of treatment. In addition, women in the clinical trial reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on day 27 or 28.

The most common adverse reactions (>/= 2%) reported while taking the oral contraceptive in a clinical trial included nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%) and weight gain (2.3%).

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FDA approves Novartis drug for high blood pressure treatment

BY Michael Johnsen

EAST HANOVER, N.J. — The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company. 

Amturnide combines the only approved direct rennin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

The FDA approval was based on data from a double-blind, active-controlled study, which showed that Amturnide provided significantly greater reductions in blood pressure compared with all dual combinations of its components.

Amturnide is approved for patients whose blood pressure is not adequately controlled with any two of its individual components and is not indicated as initial therapy for high blood pressure. Amturnide is only the third high blood pressure treatment to combine three drugs in a single pill.

"Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient," noted Alan Gradman, professor of medicine at Temple University School of Medicine. "The approval of Amturnide provides physicians with an effective treatment option that combines the benefits of the only approved direct renin inhibitor, a calcium channel blocker and a diuretic in one pill, while offering blood pressure reductions greater than two drugs alone."

High blood pressure affects nearly 75 million adults in the United States and about 1 billion adults worldwide. An estimated 31% of adults being treated with antihypertensive medications are not at their blood pressure goal. Large-scale clinical trials suggest that up to 85% of patients may need multiple medicines to achieve target levels of blood pressure control, and hypertensive patients with lower blood pressure goals or with substantially elevated blood pressure may require three or more medications.

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