Till 7 Oct. 2019, USFDA has approved two 505(b)(2)s of Bortezomib; one from Fresenius and the other from Dr. Reddy's Laboratories. These 505(b)(2)s differ from Velcade® in their compositions. Both of them avoid the use of Mannitol.
With adverse US court decision for ANDA filers, there may be no ANDA approval for Bortezomib at least till July 2022.
See below comparison between Velcade® and 505(b)(2)s of Bortezomib:
Read more on other 505(b)(2) approvals summary here
Fulvestrant 505(b)(2) approval summary
Teriparatide injection (Pfenex) 505(b)(2) approval summary
Glucagon 505(b)(2) approval summary
No comments:
Post a Comment