A new “dual-action” antidepressant is expected to be a blockbuster drug for Eli Lilly & Co. With the launch of drug duloxetine (Cymbalta™), the company hopes to reclaim the throne it lost when its tablet fluoxetine (Prozac®) lost patent protection and became generic two years earlier than expected in 2001. Generic Cymbalta is reaching the [...]
Eli Lilly and Boehringer Ingelheim have announced that Lilly has withdrawn its New Drug Application for generic duloxetine HCl for the treatment of stress urinary incontinence (SUI). The decision was based on discussions with the FDA, suggesting that the agency was not prepared to grant approval based on the data pack-age submitted. Ongoing clinical trials [...]
Eli Lilly has announced the FDA’s approval of the antidepressant duloxetine HCl (Cymbalta drug) in patients with Generalized Anxiety Disorder (GAD). GAD affects more than 6.5 million American adults each year. In three randomized, double-blind, placebo-controlled studies of more than 800 non-depressed adults with GAD, the drug significantly improved core anxiety symptoms, compared with placebo. [...]
