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Wednesday, October 3, 2018

NEWS 03 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date

Drug

NDA Sponsor

Brand Name

Prescribing information

28 Sep 2018

Cemiplimab-Rwlc Injection

Regeneron Pharmaceuticals

Libtayo

Label

01 Oct 2018

Sarecycline Tablets

Allergan 

Sarecycline

Label

02 Oct 2018

Omadacycline Tablets & Injection

Paratek Pharma

Nuzyra

Label

 

ANDA Approvals

           

Approval Date

Drug Product

ANDA

Sponsor

Corresponding RLD

Number Of Other Approved Generics

01 Oct 2018

Desvenlafaxine Succinate Er Tablets

Yichang Humanwell

Pristiq (Wyeth Pharms Inc)

Seven

*For more details on ANDA approvals click on the Drug Product Name           

 

Tentative ANDA Approvals           

Approval Date

Drug

Company

24 Sep 2018

Tofacitinib

Prinston Pharma Inc

26 Sep 2018

Linagliptin; Metformin Hydrochloride

Msn Labs Pvt 

 

 

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