| 12/28/19 | AMRN | Vascepa (sNDA) | FDA decision on expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study. |
| 12/27/19 | ITCI | Lumateperone (NDA) | FDA decision on Lumateperone for the treatment of schizophrenia |
| 12/27/19 | DRRX | POSIMIR (Resubmitted NDA) | FDA decision on POSIMIR for post-operative pain relief depot product |
| 12/25/19 | ALKS | Vumerity (diroximel fumarate) (NDA) | FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis |
| 12/15/19 | AVDL | AV001 (NDA) | FDA decision on AV001 for Hospital product |
| 12/04/19 | XLRN | Luspatercept (BLA) | FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia |