Once-daily amoxicillin approved
January 25, 2008
Moxatag 775 mg (amoxicillin extended-release, MiddleBrook Pharmaceuticals) has been approved to treat adults and children 12 and older with pharyngitis and/or tonsillitis secondary to strep throat. MiddleBrookclaims that its product is the first once-daily amoxicillin product approved in this country. Its convenient dosing should ensure better drug compliance.
OrthoEvera gets new warning
January 21, 2008
FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.
[Via FDA MedWatch]
Study Shows Zetia Doesn’t Cut Heart Attack Risk
January 15, 2008
Results from a study previously being held from the public were released showing that Zetia, an anti-hyperlipidemic medication, has been proved to provide “no medical Benefit” to patients.
Click For HealthDay report.
Watson Gets Positive Results With New Oxybutinin Topical Gel
January 8, 2008
Phase 3 study results from its pivotal study of Oxybutynin Topical Gel for the treatment of overactive bladder appear promising.
“We are extremely encouraged with the results from this trial which will support our NDA submission, and we are on track to file with FDA in the second quarter of 2008,” said Paul Bisaro, Watson’s President and Chief Executive Officer. “Additionally, we have the potential to introduce the first gel formulation for the treatment of overactive bladder in 2009.”
Complete article found here.
