New device approved by FDA for follow-on biologic
PRINCETON, N.J. The Food and Drug Administration has granted approval to Sandoz for its new drug delivery system, Omnitrope Pen 5 with liquid cartridge. The system is used with the first follow-on biologic approved by the FDA, Omnitrope, which was approved in May 2006.
Omnitrope Pen 5 with liquid cartridge is approved to be used for the long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.
A frozen dry powder version of Omnitrope was launched in the U.S. by Sandoz last January. The new device will be available in a 5 mg strength and will be marketed very soon.
“This FDA approval is another milestone in our continuing efforts to supply healthcare providers and patients with access to high-quality biologic medicines at more affordable prices, an ever-present need in the marketplace,” said Bernard Hampl, chief executive officer of Sandoz.
FDA updates labeling for birth control patch to reflect risk of blood clots
WASHINGTON The Food and Drug Administration has approved additional changes to the labeling for the Ortho Evra patch, made by Ortho McNeil Pharmaceuticals, to include the results of a new study that found users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism, which can lead to a pulmonary embolism.
The Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson conducted the study. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.
Ortho Evra is a prescription patch that releases the hormones ethinyl estradiol and norelgestromin through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE.
Women should discuss with their health care providers the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.
Study shows Avodart/Flomax combo more effective on enlarged prostate problems
PHILADELPHIA A new study that will be published in the Journal of Urology shows that men with enlarged prostates who took a combination of two medications, Avodart and tamsulosin hydrochloride, the generic version of the Astellas Pharma/Boehringer Ingelheim drug Flomax, experienced greater improvements in urinary symptoms than men prescribed either medication alone, according to published reports.
Over time, Avodart (dutasteride) shrinks the prostate, improves symptoms and arrests the enlarged prostate disease process. Tamsulosin is an alpha-blocker that relaxes the muscles in the bladder and prostate.
The study, entitled The Combination of Avodart and Tamsulosin, looked at male patients with moderate-to-severe enlarged prostate symptoms received a placebo for four weeks and then were randomized to receive Avodart and tamsulosin as combination therapy, for the remaining 24 months of the study.