IMPAX Contract

01/23/2013 Hyperion Therapeutics, Inc. HPTX Ravicti (NDA) FDA decision on Ravicti for treatment of urea cycle disorder On Jan.16, 2013, the company said the decision date will be delayed.

01/21/2013 Impax Laboratories Inc IPXL IPX066 or Rytary (NDA) FDA decision on Rytary for treatment of idiopathic Parkinson's disease

01/17/2013 NuPathe Inc. PATH Zecuity (formerly known as NP101 and Zelrix) (NDA resubmission) FDA decision on Zecuity for treatment of migraine FDA approved Zecuity on Jan.16, 2013

01/16/2013 Santarus Inc. SNTS UCERIS (NDA) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis FDA approved UCERIS on Jan.14, 2013

01/10/2013 Johnson & Johnson JNJ Canagliflozin (NDA) (Trade name INVOKANA) FDA panel to review INVOKANA for type 2 diabetes FDA panel voted 10–5 recommending approval of INVOKANA for treatment of adults with type 2 diabetes

Anonymous

Guest

Anonymous Jan 21, 2013 at 10:06: AM

#45

Anonymous

Guest

SO WHAT'S YOUR POINT --- WAS IT APPROVED OR NOT?! AND HAS ANYONE HEARD ANYTHING ABOUT GETTING OFFER? SPECIFICALLY ANYONE FROM FLORIDA?

Anonymous

Guest

Anonymous Jan 21, 2013 at 01:36: PM

#46

Anonymous

Guest

It was not approved due to pending re-inspection of the generic Heyward processing plant. Once FDA inspects the plant the approval should be soon after.

Anonymous

Guest

Anonymous Jan 21, 2013 at 02:58: PM

#47

Anonymous

Guest

Anonymous said:
It was not approved due to pending re-inspection of the generic Heyward processing plant. Once FDA inspects the plant the approval should be soon after.

FDA leverage/blackmail

Anonymous

Guest

Anonymous Jan 21, 2013 at 04:57: PM

#48

Anonymous

Guest

Has anyone heard from their recruiter or Impax DSM about the hiring process now being pushed back pending a new approval date? All I got was hang tight.

Anonymous

Guest

Anonymous Jan 21, 2013 at 11:27: PM

#49

Anonymous

Guest

yes, recruiter said contract is cancelled will be restarted when approved maybe 6-9months?