| 07/28/2013 | AVEO Pharmaceuticals, Inc. |
AVEO
| TIVOPATH aka Tivozanib (NDA) | FDA decision on TIVOPATH for advanced renal cell carcinoma |
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| 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 |
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| 07/17/2013 | QRX PHARMA |
QRXPY.PK, QRX.AX
| MOXDUO (Resubmitted NDA) | FDA panel to review MOXDUO for the treatment of acute pain |
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| 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 |
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| 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 |
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| 05/31/2013 | Flamel Technologies SA |
FLML
| Undisclosed hospital-based product (NDA) | FDA decision on undisclosed hospital-based product |
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| 05/24/2013 | Valeant Pharmaceuticals International |
VRX.TO, VRX
| IDP-108 (efinaconazole) (NDA) | FDA decision on IDP-108 for the treatment of onychomycosis |
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| 05/22/2013 | Merck & Co Inc. |
MRK
| Suvorexant tablets (NDA) | FDA panel to review Suvorexant for insomnia |
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| 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
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| 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
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| 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
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| 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
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| 04/30/2013 | Navidea Biopharmaceuticals, Inc. |
NEOP, NAVB
| Lymphoseek (NDA resubmission) | FDA decision on Lymphoseek for use as diagnostic tracing agent in lymphatic mapping procedures |
FDA approved Lymphoseek for use in lymphatic mapping on Mar.13, 2013
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| 04/30/2013 | Raptor Pharmaceuticals Corp. |
RPTP
| RP103 (NDA | FDA decision on RP103 for potential treatment of nephropathic cystinosis |
FDA approved Procysbi for nephropathic cystinosis
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| 04/18/2013 | Endo Health Solutions Inc. |
ENDP
| Aveed (NDA) | FDA panel to review Aveed for the treatment of male hypogonadism |
FDA panel voted 9-9 on safety of Aveed
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