News Focus
News Focus
Followers 24
Posts 3957
Boards Moderated 0
Alias Born 07/20/2006

Re: Regulardoc post# 16092

Sunday, 11/06/2016 10:15:41 PM

Sunday, November 06, 2016 10:15:41 PM

Post# of 20689

if I am the FDA I would think I would first look at the competitors' 20 g daily dosing, .... rather than approve a competitors' daily and thrice weekly product at the same time.


I would agree with your rationale. However, one can never predict the FDA's actions - i.e. giving Amphastar - MNTA's methods for Enoxaparin.

September 21, 2011 - 5 years already!!

http://www.streetinsider.com/Corporate+News/Momenta+(MNTA)+Sues+Amphastar,+Watson+Over+Two+Enoxaparin+Sodium+Production+Patents/6803712.html

Also - CW 3rd Q. CC - relationships that Sandoz has built with payers give us as a strong base from which to effectively launch and market our Glatopa 40 milligram product and provides us with an important first mover advantage over other potential generic competitors.

I have not seen any mention of post-marketing issues with Glatopa except for the typical, anecdotal complaints.


CW - Sandoz has successfully established a comprehensive support service hub for patients and over 7,500 patients have been treated with Glatopa since the product launched. [No mention of any major problems either here or elsewhere.]