NEWS FROM USA
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
14 Nov 2018 |
Beijing Yiling |
Femara (Novartis) |
Eleven |
|
|
14 Nov 2018 |
Scinopharm Taiwan |
Arixtra (Mylan) |
Three |
Tentative NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Comment |
|
13 Nov 2018 |
Bendamustine Hydrochloride Solution |
Apotex |
seems to be 505(b)2 of Bendeka with change in formulation |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
13 Nov 2018 |
Solifenacin Succinate |
Ajanta |
|
13 Nov 2018 |
Bendamustine Hydrochloride Solution |
Fresenius Kabi |
USFDA Inspection
Alkem's Bioequivalence Facility at Taloja completes U.S. FDA Inspection with Zero observation
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