Intimacy-enhancement pill RegenArouse recalled, FDA says
February 14th 2012An herbal pill sold as a "natural intimacy enhancement" for females has been recalled because of the undeclared presence of tadalafil (Cialis, Eli Lilly), a drug used as a treatment for male erectile dysfunction, FDA announced.
FDA approves preservative-free solution for glaucoma, ocular hypertension
February 14th 2012FDA has approved tafluprost ophthalmic solution (Zioptan, Merck) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
NCPA tells Congress: Drug shortages mean higher costs, fewer prescriptions filled
February 14th 2012Drug shortages have resulted in higher acquisition costs for pharmacies and the inability to fill prescriptions, according to a new survey, and the National Community Pharmacists Association conveyed that message to Congress.
FDA issues 3 draft guidances on biosimilars
February 14th 2012FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act signed into law in 2010.
FDA panel votes against wider use of denosumab for prostate-cancer patients
February 9th 2012An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases. The FDA?s Oncologic Drugs Advisory Committee concluded that the drug offered a statistical benefit but not a clinical benefit.