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Friday, October 26, 2018

NEWS 26 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date

Drug

NDA Sponsor

Brand Name

Prescribing information

24 Oct 2018

Baloxavir Marboxil Tablets

Shionogi 

Xofluza

Label

 

ANDA Approvals 

 

Approval Date

Drug Product

ANDA

Sponsor

Corresponding RLD

Number Of Other Approved Generics

24 Oct 2018

Dalfampridine ER Tablets

West-Ward 

Ampyra (Acorda)

Four

24 Oct 2018

Acetaminophen; Hydrocodone Bitartrate Tablets

Alvogen Pine 

None

Fourteen

 

NEW GENERICS LAUNCHES IN US

 

DRUG

COMPANY

Corresponding RLD

Annual sales quoted in press release as per IQVIA

Press Release

Arsenic Trioxide Injection 

Fresenius Kabi

Trisenox (Cephalone)

N/A

Link

                                               

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