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Human Drugs

Akorns Generic Astelin Approved

FDA approves an Akorn ANDA for a generic copy of Meda Pharmaceuticals Astelin (azelastine hydrochloride) nasal spray, indicated for treating symptoms ...

Human Drugs

Akorns Generic Astelin Approved

FDA approves an Akorn ANDA for a generic copy of Meda Pharmaceuticals Astelin (azelastine hydrochloride) nasal spray, indicated for treating symptoms ...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/17/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 5/17/2019.

Medical Devices

Warning on Unapproved Diabetes Management Devices

FDA issues a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diab...

Federal Register

Info Collection Extension for Drug Patent Listings

Federal Register notice: FDA seeks comments on an information collection extension for Applications for Food and Drug Administration Approval to Marke...

Medical Devices

Flat Medical EpiFaith Epidural Syringe Cleared

FDA clears a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution.

Federal Register

Fed Reg Correction on Device Accessories

Federal Register notice: FDA corrects a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, ...

Human Drugs

AbbVie Halts Disappointing Brain Cancer Study

AbbVie halts a Phase 3 study called INTELLANCE-1 that was evaluating depatuxizumab mafodotin in patients with newly diagnosed glioblastoma based on da...

Human Drugs

FDA Inspected 739 (26%) of Non-U.S. Drug Sites

FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018.