Replies to post #3870 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

NVS/MNTA did submit an ANDA for the Lovenox vial formulation.

[DewDiligence]

I thought Hospira was a relatively serious company; why do they sacrifice their credibility on this program? It's not like they are subject to Zebra's Law.

HSP presumably licensed the vial formulation of a Lovenox knockoff from a foreign company and submitted the specs to the FDA. They did not seriously expect FDA approval, IMO, but they had almost nothing to lose by trying. It probably would have taken more work than HSP thought the project was worth to amend the formulation for prefilled syringes.

[Rocky3]

"I thought Hospira was a relatively serious company; why do they sacrifice their credibility on this program? It's not like they are subject to Zebra's Law."

As I now understand the rules, we may not know who has filed under paragraph 3. So Hospira may have already filed for all applications. It surely sounds as though MNTA thinks that there may be many undisclosed applications already pending before the FDA.