NEWS FROM USA
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
30 Oct 2018 |
Zydus |
Urso 250 (Allergan ) |
Three |
|
|
31 Oct 2018 |
Hikma Pharma |
Zytiga (Janssen) |
None |
|
|
31 Oct 2018 |
Zydus Pharms |
Levitra (Bayer) |
Three |
|
|
31 Oct 2018 |
Crossmedika |
Levitra (Bayer) |
Three |
|
|
31 Oct 2018 |
Amneal |
Levitra (Bayer) |
Three |
*Highlighted approval is the first Generic approval for corresponding RLD
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
26 Oct 2018 |
Methylergonovine Maleate |
Teva |
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Daptomycin New |
Injection |
Cubicin RF |
30 Aug 2018 |
Open First to File |
|
Doxylamine Succinate and Pyridoxine Hydrochloride |
ER Tablets |
Bonjesta |
28 Aug 2018 |
Open First to File |
|
Enalapril Maleate |
Oral Solution |
Epaned |
31 Aug 2018 |
Open First to File |
|
Esomeprazole Magnesium |
DR oral suspension |
Nexium |
24 Sep 2018 |
Open First to File |
*Open First to file means there was no NCE exclusivity at the time of filing date
USFDA INSPECTION
FDC receives EIR from US health regulator for Waluj plant
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