Till 20 Aug.
2019, USFDA has approved two 505(b)2 s of Fulvestrant; one from Fresenius and the
other from Teva.
These
505(b)2s differ from Faslodex® in their compositions. Fresenius’
505(b)2 also has improved storage.
Regarding
generics, Sandoz has already launched generic version of Faslodex® in May 2019.
Below table
highlights the differences between Faslodex®
and 505(b)2s of Fulvestrant.
Read more on other 505(b)(2) approvals summary here
Bortezomib 505(b)(2) approval summary
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