Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

Jun 19 2017

• By Bridget Silverman

Keeping Track Feature image

Related Content

Managing The World’s First Blockbuster Generic: An Interview With Sandoz’s George

Feb 20 2012

Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns

May 11 2017

Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA

Jul 19 2016

Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018

Oct 29 2016

Keeping Track: Gilead Aims To Expand TAF To HBV; BioMarin's Kyndrisa Get Complete Reponse

Jan 18 2016

Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

Jun 12 2017

Advair Generic Approval Uncertain Despite US FDA Denial Of Sandoz Petition

Mar 29 2017

Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

Jun 13 2017

Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA

Jun 12 2017

Hikma's CRL Proves GSK's Witty Was Right: Generic Advair Is Hard

May 11 2017

Keeping Track: KemPharm Apadaz Delay; Cholera Vaccine Approved

Jun 13 2016

Related Companies

DMK Pharmaceuticals Corp.

Novartis AG

GSK plc

Coherus Oncology, Inc.

Viatris Inc.

Kaléo Pharmaceutical Inc.

Hikma Pharmaceuticals plc

Oriel Therapeutics Inc.

Amgen, Inc.

Novartis AG

Apotex Inc.

Additional Topics

Approvals Biosimilars Complete Response Letters Generic Drugs Regulation BioPharmaceutical

More from Approvals

More from Product Reviews

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window