NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
28 Sep 2018 |
Cemiplimab-Rwlc Injection |
Regeneron Pharmaceuticals |
Libtayo |
|
|
01 Oct 2018 |
Sarecycline Tablets |
Allergan |
Sarecycline |
|
|
02 Oct 2018 |
Omadacycline Tablets & Injection |
Paratek Pharma |
Nuzyra |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
01 Oct 2018 |
Yichang Humanwell |
Pristiq (Wyeth Pharms Inc) |
Seven |
*For more details on ANDA approvals click on the Drug Product Name
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
24 Sep 2018 |
Tofacitinib |
Prinston Pharma Inc |
|
26 Sep 2018 |
Linagliptin; Metformin Hydrochloride |
Msn Labs Pvt |
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