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floblu14

11/06/16 10:15 PM

#16093 RE: Regulardoc #16092

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.]
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jbog

11/07/16 1:32 PM

#16094 RE: Regulardoc #16092

Regulardoc,

There's no difference between the two items except the Label and dose. I believe some of the 40mg filers haven't even filed the 20mg dose unless they filed without any press releases.