By: Bethsy Jacob, PharmD Candidate 2014 – On January 18, 2013, the U.S. Food and Drug Administration (FDA) announced a new approval for Botox, generically known as OnabotulinumtoxinA. Patients diagnosed with urinary incontinence due to an overactive bladder can be prescribed Botox, if they are unable to take or are unresponsive to anticholinergic medications.  This…

By: Bhavini Shah, PharmD Candidate c/o 2013  – Fycompa® (perampanel) has received the U.S. Food and Drug Administration (FDA) approval for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.1  The drug, manufactured by Eisai Inc., is already approved for use in Iceland,…

By: Tamara Yunusova, Staff Editor – On December 3, 2012, the U.S. Second Circuit Court of Appeals became the first court in the nation to authorize off-label drug promotion under the First Amendment.  The heavily-disputed ruling, which is headed for further appeal, will have far-reaching implications for pharmaceutical companies and drug regulation policy. In a…