FDA approves Watson oral contraceptive
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%).
FDA approves Novartis drug for high blood pressure treatment
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.
FDA approves Merck’s Gardasil for prevention of anal cancer
WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.
According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.
In the United States, an estimated 75% to 80% of males and females will be infected with HPV in their lifetime. For most, HPV will clear on its own. However, for those who don’t clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women.
There is no way to predict who will or won’t clear the virus.
Anal cancer affects both men and women, with approximately 60% of cases occurring in women. According to the American Cancer Society, it is estimated that approximately 2,000 men and more than 3,000 women will have been diagnosed with anal cancer in 2010.
There is no standardized screening recommended for the general population for anal cancer, and many people are diagnosed when the disease is more advanced.