Tag archive for ‘Makena AdCom Meeting’
AMAG Pharmaceuticals: AdCom Votes 9 to 7 to Remove Makena from the Market, but I Don’t Think It Will Happen: AMAG (AMAG, $9.80), Antares Pharma (ATRS, $3.40, Buy)
The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs on the panel voted to keep Makenna on the market and to do additional studies to properly define its role in the management of women with singleton pregnancies who previously have had a preterm birth. […]
AMAG Pharmaceuticals (AMAG, $12.20); Antares (ATRS, Buy, $3.59) What Will FDA AdCom Recommend on Makena in the Aftermath of Failed Prolong Trial?
Key Conclusions I believe that there is a 95% probability that Makena will remain on the market and only a 5% chance that it could be withdrawn. I think that results of PROLONG will be incorporated into the Makena label and the FDA may or may not ask for another trial. There is no approved […]