| 09/01/2013 | Otsuka Holdings Co., Ltd. |
OTSKF.PK
| Tolvaptan (NDA) | FDA decision on Tolvaptan for the treatment of autosomal dominant polycystic kidney disease |
|
|
| 08/26/2013 | QRX PHARMA |
QRXPY.PK, QRX.AX
| MOXDUO (Resubmitted NDA) | FDA decision on MOXDUO for the treatment of acute pain |
|
|
| 07/28/2013 | AVEO Pharmaceuticals, Inc. |
AVEO
| TIVOPATH aka Tivozanib (NDA) | FDA decision on TIVOPATH for advanced renal cell carcinoma |
FDA issued Complete Response Letter for Tivozanib on June 10, 2013
|
|
| 07/23/2013 | AbbVie |
ABBV
| HUMIRA (sBLA) | FDA panel to review HUMIRA injection, for addnl indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis |
|
|
| 07/18/2013 | Merck & Co Inc. |
MRK
| Sugammadex sodium injection (NDA) | FDA panel to review Sugammadex sodium for the proposed indications of routine reversal of moderate and deep neuromuscular blockade |
|
|
| 07/17/2013 | QRX PHARMA |
QRXPY.PK, QRX.AX
| MOXDUO (Resubmitted NDA) | FDA panel to review MOXDUO for the treatment of acute pain |
|
|
| 06/15/2013 | Delcath Systems Inc. |
DCTH
| CHEMOSAT with melphalan hydrochloride (NDA resubmission) | FDA decision on CHEMOSAT with melphalan hydrochloride for metastatic melanoma in liver |
|
|
| 06/05/2013 | Celgene Corporation |
CELG
| REVLIMID (sNDA) | FDA decision on REVLIMID for treatment of patients with relapsed or refractory mantle cell lymphoma after prior therapy |
FDA approved REVLIMID for treatment of patients with relapsed or refractory mantle cell lymphoma after prior therapy
|
|
| 05/31/2013 | Flamel Technologies SA |
FLML
| Undisclosed hospital-based product (NDA) | FDA decision on undisclosed hospital-based product |
FDA approves the undisclosed hospital-based product. It is Bloxiverz, a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
|
|
| 05/24/2013 | Valeant Pharmaceuticals International |
VRX.TO, VRX
| IDP-108 (efinaconazole) (NDA) | FDA decision on IDP-108 for the treatment of onychomycosis |
FDA issued Complete Response Letter for Efinaconazole on May 28, 2013
|
|
| 05/22/2013 | Merck & Co Inc. |
MRK
| Suvorexant tablets (NDA) | FDA panel to review Suvorexant for insomnia |
FDA panel backs Suvorexant to treat insomnia at lower starting doses.
|
|
| 05/12/2013 | GlaxoSmithKline PLC |
GSK.L, GSK
| BREO ELLIPTA (NDA) | FDA decision on BREO ELLIPTA for chronic obstructive pulmonary disease |
FDA Approved BREO ELLIPTA for chronic obstructive pulmonary disease on May 10, 2013
|
|
| 05/12/2013 | THERAVANCE, INC. |
THRX
| BREO ELLIPTA (NDA) | FDA decision on BREO ELLIPTA for chronic obstructive pulmonary disease |
FDA approved BREO ELLIPTA for chronic obstructive pulmonary disease on May 10, 2013
|
|
| 05/02/2013 | AVEO Pharmaceuticals, Inc. |
AVEO
| Tivozanib (NDA) | FDA panel to review Tivozanib for advanced renal cell carcinoma |
FDA panel voted against recommending approval of Tivozanib for advanced renal cell carcinoma
|
|
| 04/30/2013 | TITAN PHARMACEUTICALS INC |
TTNP.OB
| Probuphine (NDA) | FDA decision on Probuphine for the maintenance treatment of adult patients with opioid dependence |
FDA issues Complete Response Letter for Probuphine
|
|