UPDATE 1-AMAG expects FDA action on anemia drug within days
* AMAG sees no outstanding issues
* AMAG CEO confident Feraheme will win approval
LOS ANGELES, June 29 (Reuters) - AMAG Pharmaceuticals (AMAG.O) expects a decision on its injectable anemia drug in coming days, after not receiving a go-ahead from federal drug regulators on Monday.
The Federal Drug Administration had informed AMAG that it had not acted on AMAG's drug application as of Monday, but expected to issue an action letter "within the next few days," the company said in a statement, adding that the agency had not requested additional information.
"It is the company's understanding that there are no outstanding issues regarding the Feraheme New Drug Application," AMAG said in its statement. [ID:nWNAB3090]
AMAG's CEO Brian Pereira told Reuters this month he was confident the drug, known as Feraheme, would win approval. Factory issues that had twice delayed the drug's U.S. approval had been resolved and an 80-person salesforce was ready to roll, the executive said on June 11. [ID:nN11515909]
Feraheme is intended for the estimated 375,000 Americans with anemia who are on dialysis, a blood cleansing procedure. It is also geared for the 1.6 million Americans with kidney disease who do not yet require dialysis.
Many anemic kidney patients now receive Amgen Inc's (AMGN.O) Epogen or Johnson & Johnson's (JNJ.N) Procrit, red blood cell boosters that have come under intense scrutiny over safety and overuse concerns. (Reporting by Edwin Chan; Editing by Gary Hill)
