Sandoz`s Generic Ferumoxytol Receives Approval in US
On February 10, 2016, the United States Food and Drug Administration (FDA) revealed its biweekly updated Paragraph IV Certification list for which the Agency has received a first substantially complete abbreviated new drug application (ANDA) challenging at least one Orange Book listed patent. Notably, the list of the targeted New Drug Applications (NDAs) were relatively recently approved by the FDA between June 30, 2009 and December 23, 2014. This is not necessarily surprising considering none of these approvals involve a new compound. With respect to these NDAs, an ANDA with a Paragraph IV Certification was filed on average approximately within two and one-half (~2.5) years after final approval of the respective NDA. An ANDA with a Paragraph IV challenge for Dyloject was submitted the fastest within three hundred fifty-seven (357) days after NDA Approval while an ANDA with a Paragraph IV challenge for Feraheme was submitted two thousand three hundred forty-eight (2,348) days after NDA Approval. Assuming the NDA holder or the holder of the patent listed in the Orange Book for these products challenges within the statutory forty-five (45) days of receipt of the Paragraph IV Notice, the ANDA will be subject to a thirty (30) month Automatic Stay (Automatic Stay) during which time the FDA will not be able to approve the subject ANDA.
FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe