Showing posts with label accepted. Show all posts
Showing posts with label accepted. Show all posts

Thursday, May 16, 2013

BRIEF-AMAG Pharmaceuticals says FDA accepted SNDA for Feraheme label expansion

March 6 (Reuters) - AMAG Pharmaceuticals Inc :

* Announces FDA acceptance of supplemental new drug application for feraheme

label expansion to include iron deficiency anemia patients who cannot take

oral iron

* Says FDA has set October 21, 2013 as a target date for completion of their

review * Source text

* Further company coverage

((Bangalore Newsroom; +1 646 223 8780))


View the original article here

Thursday, May 2, 2013

BRIEF-Antares Pharma says FDA accepted Otrexup NDA

Feb 27 (Reuters) - Antares Pharma Inc :

* Announces FDA acceptance of new drug application for Otrexup(TM)

* Says FDA has assigned a prescription drug user fee act (pdufa) date of

October 14, 2013 * Source text * Further company coverage

((Bangalore Newsroom; +1 646 223 8780))


View the original article here