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An 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 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.

An 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.

FDA has approved lisdexamfetamine dimesylate (Vyvanse, Shire) capsules, (CII) as a maintenance treatment for adults with ADHD. Vyvanse was already approved as a treatment for ADHD in patients aged 6 to 17 years.

U.S. drug expenditures remained relatively flat in 2011, but a new report projects that drug costs will rise between 3% and 5% across all healthcare settings this year. .

The author tries his hand at practicing pharmacy in the land down under. He is enjoying his new adventure, despite facing some challenges.

FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.