NEWS 28 JUNE 2018

• NDA approvals (USA)

1. JazzPharmaceuticals Announces FDA Acceptance of Supplemental New Drug Applicationfor sodium oxybate to Treat Cataplexy and Excessive Daytime Sleepiness in PedsiatricNarcolepsy Patients.

• Array biopharma announces fda approval of encorafenib in combination with binimetinib.

• IND approvals(USA)

1. InflaRx Receives IND Approval from the FDA to Start itsPhase II Clinical Trial of IFX-1 in ANCA-Associated Vasculitis.

*For browsing official press releases click on the respective news item.

NEWS 27 JUNE 2018

• Updates from USFDA

1. FDA panel rejects Pain Therapeutics abuse-deterrent opioid Oxycodone extended-release capsules.
2. FDA publishes an updated List of Off-Patent,Off-Exclusivity Drugs without an Approved Generic

*For browsing official press releases click on the respective news item.

NEWS 26 JUNE 2018

• New NDA approvals (USA)

1. Plazomicin Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infection.
2. GW Pharmaceuticals plc and its U.S. Subsidiary Greenwich Biosciences Announce FDA Approval of cannabidiol oral solution – the FirstPlant-derived Cannabinoid Prescription Medicine.

• New ANDA Approvals (USA)

1. US FDA approves Aurobindo Pharma's generic Ertapenem Injection.

*For browsing official press releases click on the respective news item.