Biotech Values

[Regulardoc]

My sources at a major PBM inform that me that Sandoz (or its vendor) are "reconfiguring the syringe device" due to the reported premature mechanism release. They have also said that this has led to a supply problem, so they are reluctant to add it to their formulary and remove Lovenox at the present time. I am not sure if the "supply issue" is simply the fact that Sandoz only has the capacity to supply 30-40% of the market and is unrelated to the syringe issue.

Anybody out there with additional info, particluarly those who are pharmacists?

Also, if the delivery device is reconfigured, does the FDA have to evaluate it?

Thanks.