Biotech Values

[go seek]

Also keep in mind Teva's ANDA was submitted 7 years ago...

back then, i suspect, the FDA did not provide 'specific' guidance on what was required for approval.

today we know...
1. If a manufacturer wants to make a generic enoxaparin sodium, it has to design a manufacturing process that is capable of reproducing these distinct features of the drug.

2. Demonstration of “sameness” for enoxaparin sodium requires “state-of-the-art” analytical methods to show that the structural features of oligosaccharides in the generic enoxaparin sodium are equivalent to those in Lovenox.

also ref FDA links in #msg-52581746