Calendar

Week of Dec 9, 2013

Dec 10, 2013approval4646d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

Dec 10, 2013approval4646d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

Dec 12, 2013approval4644d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

Dec 12, 2013approval4644d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

Dec 12, 2013approval4644d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

Dec 12, 2013approval4644d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

Dec 12, 2013approval4644d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

Dec 13, 2013approval4643d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

Dec 13, 2013approval4643d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

Sponsor: VERTEX PHARMS. Form: TABLET. Route: ORAL

Dec 13, 2013approval4643d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

Dec 13, 2013approval4643d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

Dec 13, 2013approval4643d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL