Table 3. Agents pending FDA approval: August 16, 2014 through September 15, 2014.

Generic name	Brand name (Company)	Indication and comments
Recommended for approval by an FDA advisory panel
Aspirin/statin/antihypertensive		Potential for a fixed-combination antihypertensive, aspirin, and statin to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease (secondary prevention). Committee agreed with the concept to help improvement adherence, but concerns were expressed regarding the ability to achieve recommended target goal for lipid levels and blood pressure.
Recommended for NON-approval by an FDA advisory panel
Nebivolol/valsartan	(Forest Laboratories)	Fixed combination (5/160 mg, 10/160 mg, 10/320 mg, and 20/320 mg) for the treatment of hypertension. The committee vote was 6 to 4 recommending against approval.
Agents scheduled for review by an FDA advisory panel
Secukinumab	(Novartis)	Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
Testosterone undecanoate, oral	(Clarus Therapeutics)	Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
Varenicline	Chantix (Pfizer)	Evaluation of the risk of serious neuropsychiatric adverse events and options for addressing this risk