FDA again rejects single-dose use of AMAG's Makena
Thursday, November 19, 2015
AMAG Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected a single dose of its hormone injection used to reduce the risk of premature birth, the agency's second rebuff in six months.
The company's shares fell 8 percent to $26.13 in after-hours trading on Wednesday.
FDA had rejected the company's application in May and requested more information on its manufacturing procedures.
The hormone injection, Makena, is currently approved and marketed in multi-dose and remains unaffected by FDA's Wednesday decision.
AMAG gained access to Makena following its acquisition of privately held Lumara Health Inc in September last year for $675 million.
The multiple dose is approved to lower the risk of premature birth in pregnant women who has had one premature baby.
Makena generated net sales of $65.2 million for the quarter ended Sept. 30, up 36 percent from a year earlier.
reuters.com
