Biotech Values

[jq1234]

Today I looked at FDA acessdata for some generic approvals. I read the generic Lovenox approval letter for the first time. It's interesting to learn MNTA/Sandoz filed ammendment total 47 times between January 3, 2007 through March 9, 2007 alone. Wow!

This is in reference to your abbreviated new drug application(ANDA) dated August 26, 2005, submitted pursuant to section505(j) of the Federal Food, Drug, and Cosmetic Act (the Act),for Enoxaparin Sodium Injection USP, 100 mg/mL, [packaged in30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL], and 150 mg/mL [packaged in 120 mg/0.8 mL and 150 mg/1 mL](Prefilled Single-dose Syringes with Automatic Safety Device)(Preservative-Free).

Reference is made to your amendments dated July 6, August 31,September 7, October 5, November 9, November 17, November 29,December 28, 2006; January 5, February 20, February 27, March23, March 26, June 8, September 19, October 26, 2007; February13, February 27, June 2, June 13, September 23, September 25,November 20, November 21, December 12, 2008; January 20,February 27, March 2, March 12, March 20, April 8, May 21, June1, June 3, June 19, June 25, July 1, August 6, September 18,September 30, October 7, October 21, December 1, and December30, 2009; and January 13, January 18, March 15, April 28, andMay 26, 2010. Reference is also made to your communicationsdated June 22, and September 8, 2006; multiple amendments (47submissions) dated January 3, 2007 through March 9, 2007; andJune 13, and September 16, 2008.

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077857s000ltr.pdf