NEWS FROM USA
ANDA Approvals
|
Approval Date |
Drug |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
07 Sep 2018 |
Octreotide Acetate Injection |
USV North America |
Sandostatin (Novartis) |
Five |
|
10 Sep 2018 |
Ibuprofen Tablets |
HEC Pharma |
N/A |
Thirteen |
|
10 Sep 2018 |
Metformin Hydrochloride ER Tablets |
Prinston |
Glucophage XR (BMS) |
Eighteen |
|
10 Sep 2018 |
Chlorpromazine Hydrochloride Tablets |
Amneal |
N/A |
One (USL Pharma) |
|
10 Sep 2018 |
Fenofibrate Micronized Capsule |
Ajanta |
N/A |
Eight |
|
11 Sep 2018 |
Atovaquone Oral solution |
Lupin |
Mepron (GSK) |
Two (Amneal, Paddock) |
|
11 Sep 2018 |
Carmustin injection |
Navinta |
BICNU (Alkem) |
None |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
11 Sep 2018 |
Dimethyl fumarate capsules |
Alkem |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Neostigmine Methylsulfate Injection |
Dr Reddy’s Laboratories |
Bloxiverz (Avadel Legacy) |
111 Mn $ |
|
|
Esmolol injection in single dose plastic bag |
Mylan |
Brevibloc (Baxter) |
126 Mn $ |
|
|
Chlorpromazine Hydrochloride Tablets |
Amneal |
N/A |
207 Mn $ |
USFDA INSPECTIONS
Sun Pharma confirms USFDA inspection of Mohali plant.
NEWS RELATED TO GENERIC PATENT LITIGATIONS
Rifaximin: Bausch Health Announces Resolution Of XIFAXAN Intellectual Property Litigation with Actavis (Teva)- Permitting launch on or after 1 Jan. 2028
Hydorcodone Bitartarate: Pernix Therapeutics Holdings, Inc.’S Subsidiaries File Notice Of Appeal In Patent Litigation Concerning Zohydro® ER With BeadTek®
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