NEWS FROM USA
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
12 Oct 2018 |
Fluocinolone Acetonide Implant |
Eyepoint Pharms |
Yutiq |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
09 Oct 2018 |
Aurobindo Pharma |
Zemplar (Abbvie) |
Seven |
|
|
15 Oct 2018 |
Glenmark |
Westcort (Sun Pharma) |
Two (Perrigo New York & Taro) |
|
|
15 Oct 2018 |
Dr Reddy |
Aggrenox (Boehringer Ingelheim) |
Seven |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
10 Oct 2018 |
Lurasidone Hydrochloride |
Lupin |
|
10 Oct 2018 |
Linagliptin; Metformin Hydrochloride |
Zydus |
|
12 Oct 2018 |
Testosterone |
Amneal |
|
12 Oct 2018 |
Levothyroxine Sodium |
Maia Pharms |
|
12 Oct 2018 |
Mirabegron |
Aurobindo |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Testosterone |
Perrigo |
Androgel (Abbvie) |
$ 1 Billion |
New Strength Approval For Existing NDA
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Strength |
|
11 Oct 2018 |
Rivaroxaban |
Janssen Pharma |
Xarelto |
2.5 mg |
OTHER NEWS FROM USA
Court Affirms Prior Decisions Finding Copaxone® 40 mg/ml Patents Invalid- a milestone for NATCO and its market ing partner Mylan (Link)
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