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POMALYST (nda204026)- (1MG,2MG,3MG,4MG)

POMALIDOMIDE BRISTOL
1MG,2MG,3MG,4MG
Yes No
2031-Dec-21 Expired
None None
None No
POMALYST is a thalidomide analogue indicated, for the treatment of adult patients:  in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.  with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)
3 1 0
Total Other Developers 5
Drugs with Suitability No
1MG ** ** - - -
2MG ** ** - - -
3MG ** ** - - -
4MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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