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Vertex Pharmaceuticals Has Received Approval From The US Food and Drug Administration
Feb 25, 2014US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic ...
Tags: FDA Approval, Vertex, Kalydeco sNDA
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Teva Pharmaceuticals Received Approval for sNDA for Three-Times-a-Week COPAXONE 40mg/mL
Feb 7, 2014Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
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Bayer HealthCare Has Failed to Win The Backing of The US FDA's Cardiovascular
Jan 20, 2014Bayer HealthCare has failed to win the backing of the US FDA's Cardiovascular and Renal Drugs Advisory Committee to expand the use of its oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard ...
Tags: FDA Panel, ACS Patients
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U.S. Food and Drug Administration (FDA) Has Accepted for Review The SNDA
Jan 16, 2014Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Application ...
Tags: Iroko Pharmaceuticals, FDA, ZORVOLEX, osteoarthritis pain
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FDA Has Accepted for Review The Supplemental New Drug Application
Jan 15, 2014Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Application ...
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Navidea Biopharmaceuticals Has Submitted a Supplemental New Drug Application
Dec 19, 2013Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
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FDA Accepted for Review US-Based Biopharmaceutical Firm Nps Pharmaceuticals' Supplemental
Nov 15, 2013The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
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AMAG Pharmaceuticals Has Received a Notice of Three-Month Extension From FDA
Oct 18, 2013AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
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The FDA Has Approved The Use of Astellas Pharma US' Mycamine
Jun 26, 2013The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, ...
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The USFDA Has Accepted Pfizer's Supplemental New Drug Application
Jun 25, 2013The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
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The FDA Has Cleared Celgene's sNDA for Revlimid for Refractory Mantle Cell Lymphoma
Jun 7, 2013The FDA has cleared Celgene's supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The approval follows positive data from MCL-001 phase ...
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The USFDA Has Accepted Teva Pharmaceutical Industries' sNDA
May 31, 2013The USFDA has accepted Teva Pharmaceutical Industries' supplemental new drug application (sNDA) for reviewing Copaxone (glatiramer acetate injection) 40mg/1mL. Indicated for patients with relapsing-remitting multiple sclerosis (RRMS), the ...
Tags: Drug Application, Medicine
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Celgene International Has Obtained FDA Priority Review Status for Abraxane
May 24, 2013Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
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The USFDA Approval Adds to Expansion of The Vascepa Manufacturing Supply Chain
Apr 23, 2013The USFDA has approved Amarin supplemental new drug application for Chemport as additional Vascepa active pharmaceutical ingredient supplier. The approval adds to the company's planned expansion of the Vascepa manufacturing supply chain ...
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FDA Has Accepted for Review Amag Pharmaceuticals' Supplemental New Drug Application
Mar 8, 2013The US Food and Drug Administration (FDA) has accepted for review AMAG Pharmaceuticals' supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for Intravenous (IV) use. The sNDA filed is to expand the indication for ...
Tags: FDA, Pharmaceuticals, oral iron treatment