NEWS FROM USA
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Bosutinib (400 mg) |
Tablets |
Bosulif |
15 Oct 2018 |
Post NCE-1 submission for new strength |
|
Dapagliflozin And Metformin hydrochloride |
Extened release Tablets |
Xigduo XR |
29 Oct 2018 |
Post NCE-1 submission for new strength |
|
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate |
Tablets |
Stribild |
04 Oct 2018 |
Open filing |
|
Naloxegol |
Tablets |
Movantik |
17 Sep 2018 |
NCE-1 |
|
Pirfenidone |
Capsules |
Esbriet |
15 Oct 2018 |
NCE-1 |
|
Pirfenidone |
Tablets |
Esbriet |
15 Oct 2018 |
NCE-1 |
|
Rivaroxaban (2.5 mg) |
Tablets |
Xarelto |
15 Nov 2018 |
Post NCE-1 submission for new strength |
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Clobazam tablets |
Hikma |
Onfi (Lundbeck) |
$601 Million |
|
|
Clobazam oral suspension |
Hikma |
Onfi (Lundbeck) |
$260 Million |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
10 Dec 2018 |
Aurobindo |
Rapaflo (Allergan) |
Six |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
11 Dec 2018 |
Dapsone |
Taro Pharma |
If you have any query/suggestion then please write us at pharmacaption@gmail.com
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