Tag archive for ‘Makena Auto-Injector’
AMAG Pharmaceuticals: Trying to Project 2019 Sales for the Makena Franchise (AMAG, $24.45, Buy)
Investment Thesis The investment outlook for AMAG in 2019 is primarily about Makena and this report focuses almost entirely on how much of the franchise can be maintained by the new auto-injector dosage form in the face of generic competition to the older intramuscular formulations. The Wall Street consensus 2019 sales estimate of around $200 […]
Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)
AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance. AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares. AMAG revealed that it will […]