NEWS FROM USA
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Edoxaban Tosylate |
Tablets |
Savaysa |
28 Jan. 2019 |
NCE-1* |
|
Morphine
Sulfate |
Tablets |
Morphabond ER |
28 Jan. 2019 |
Open First to File (Non NCE) |
|
Palbociclib |
Capsules |
Ibrance |
4 Feb. 2019 |
NCE-1 |
*Actual NCE-1 date for Edoxaban was 8 Jan. 2019. However, due to US government shutdown that lasted till 25 Jan. 2019, the date on which FDA has received ANDA for review should be the first working day after shutdown i.e. 28 Jan. 2019.
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
19 Mar 2019 |
Amphastar |
Lovenox (Sanofi-Aventis) |
One (Sandoz) |
|
|
19 Mar 2019 |
Zydus |
ZOVIRAX (BAUSCH) |
More than 10 |
Tentative ANDA Approvals
|
Approval Date |
Drug |
Company |
|
27 Feb 2019 |
Anchen |
Other news from US
Liraglutide (Teva): Novo Nordisk settles US patent litigation case on Victoza® (liraglutide) with Teva
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