NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
Company |
Brand Name |
Prescribing information |
|
14 Sep 2018 |
Midazolam injection (50 mg/ml) |
Meridian |
Seizalam |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
14 Sep 2018 |
Gland |
Fusilev (Spectrum)-Discontinued |
Four |
|
|
17 Sep 2018 |
Hetero |
Norvir (Abbvie) |
One (West-Ward) West-ward’s Patent challenge exclusivity expired on 16 Sep. 2018 |
|
|
17 Sep 2018 |
Amneal |
|||
|
17 Sep 2018 |
Aurobindo |
*For more details on ANDA approvals click on the Drug Product Name
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
13 Sep 2018 |
Lansoprazole |
Zydus |
|
14 Sep 2018 |
Ingenol Mebutate |
Perrigo |
|
14 Sep 2018 |
Silodosin |
Ajanta |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Ritonavir tablets |
Camber (Hetero) |
Norvir (Abbvie) |
N/A |
USFDA FACILITY INSPECTIONS
Strides Pharma completes USFDA inspection at Bangalore facility
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