Biotech Stocks Facing FDA Decision In February

AMAG Pharmaceuticals
AMAG Pharmaceuticals

AMAG Pharmaceuticals Inc (AMAG) awaits FDA decision on expanded use of its lead drug Feraheme on February 2, 2018.

Feraheme, an iron replacement therapy, received the U.S. regulatory nod in June 2009 for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Now, the Company is seeking to expand the drug’s use to include all eligible adult patients with iron deficiency anemia who have failed or cannot tolerate oral iron treatment.

This is the second time that AMAG is at the FDA altar seeking approval of expanded use of Feraheme.

The FDA had turned down the Company’s request to approve the expanded use of Feraheme for the broader iron deficiency anemia indication in January 2014.

Will second time prove the charm for the label expansion of Feraheme? We need to wait and see.

AMAG closed Thursday’s (Jan.25) trading at $14.65, up 2.09%.