NEWS FROM USA
New Paragraph IV filing
|
DRUG |
Dosage form |
Corresponding RLD |
Date of Submission |
Type of Submission (Based on Date) |
|
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Sodium Sulfate and Ascorbic Acid |
For oral solution |
Plenvu |
6 Dec. 2018 |
Open First to File (Non NCE) |
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
13 Feb. 2019 |
Triclabendazole tablets |
Novartis |
Egaten |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
11 Feb 2019 |
Novast |
N/A |
Three |
|
|
11 Feb 2019 |
Orit |
N/A |
Nine |
|
|
11 Feb 2019 |
Custopharm |
Bentyl (Allergan) |
Eight |
|
|
11 Feb 2019 |
Apotex |
Omeprazole (Dexcel) |
Two (Dr Reddys, Sun Pharm) |
|
|
11 Feb 2019 |
Strides |
Triamcinolone Acetonide (Mylan) |
Eight |
|
|
13 Feb 2019 |
Zydus |
Dyazide (GSK) |
Four |
Other news from the USA
Esketamine From Janssen Pharma: FDA Advisory Committee Recommends Approval of SPRAVATOTM (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression.
Golodirsen from Sarepta: Sarepta Announces FDA Acceptance of Golodirsen NDA for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Pitolisant from Harmony Biosciences: Harmony Bioscience announced the USFDA has accepted for filing the NDA for pitolisant in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments.
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