Replies to post #113094 on Biotech Values

[rob1]

Heh- I was doing the same thing. Found 3 cases so far- the times vary A LOT: 4 months on the low end to ending up with a 'not approvable' 4 months later. Not sure how comparable this is, but looks like a lot of room for variation. IDK.

*4 months
Phentermine -
Submission 1997
Deficiency - Jan. 27 1997
Minor Def. July 21, 1998
Response Aug. 20, 1998
Fax Def Oct 16, 1998
Amend Response Oct 26, 1998
Approvable Nov 3, 1998

*Not approvable
74944 Atracurium Besylate Chemistry Review
Submission - Aug 21, 1996
Minor deficiency letter - May 8, 1997
Amendment - May 21, 1997
Micro review acceptable June 10, 1997
Labeling review deficient - July 1, 1997
Not approvable letter- Sept 22, 1997

*8 months
Feb. 12, 1998--SangStat, The Transplant Company
Minor Deficiency letter
October 31, 1998, the FDA granted marketing clearance and an AB (bioequivalent) rating to SangStat's SangCya

[dewophile]

minor vs major deficiency letter

i don't have experience in this area - perhaps genisi can chime in since she follows teva closely. dew is strangely silent thus far. regardless past history may not apply here since lovenox is a complex product adn unique so rate of conversion of minor deficiency to approval for small molecules may be different