Table 2. New dosage forms and indications approved by the FDA: August 16, 2014 through September 15, 2014.
| Generic name |
Brand name (Company) |
Indication and comments |
| New dosage forms/strength/route of administration | ||
| Abacavir, dolutegravir, and lamivudine |
Triumeq (ViiV HealthCare) |
Treatment of HIV-1 infection with a once-daily, single-tablet regimen that contains 600 mg of abacavir (nucleoside analogue reverse transcriptase inhibitor), 50 mg of dolutegravir (integrase strand transfer inhibitor), and 300 mg of lamivudine (nucleoside analogue reverse transcriptase inhibitor) |
| New indications | ||
| Apixaban |
Eliquis (Bristol-Myers Squibb) |
Treatment of deep vein thrombosis and pulmonary emboli and reduction of risk of recurrent deep vein thrombosis and pulmonary emboli following initial therapy |
| Diclofenac |
Zorvolex (Iroko Pharmaceuticals) |
Management of osteoarthritis pain |
| Eltrombopag |
Promacta (GlaxoSmithKline) |
Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy |
| Enalapril maleate powder for oral solution |
Epaned (Silvergate Pharmaceuticals) |
Previously approved only for the treatment of hypertension; indication expanded to include treatment of symptomatic heart failure and treatment of asymptomatic left ventricular dysfunction |
| Enzalutamide |
Xtandi (Medivation/Astellas Pharma) |
Advanced prostate cancer in men who have not yet received chemotherapy |
| Lacosamide |
Vimpat (UCB) |
Monotherapy for the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older |