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Drug Application
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AquaBounty Secures FDA Approval for Salmon Production in Indiana
May 3, 2018AquaBounty Technologies has secured approval from the US Food and Drug Administration (FDA) to raise AquAdvantage Salmon at its land-based contained facility near Albany, Indiana. The FDA previously approved AquaBounty’s New Animal ...
Tags: AquaBounty, Salmon Production
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Afrezza Hopes That Its Inhalable Insulin Product Will Be a Gamechanger for Diabetics
Apr 8, 2014Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza). Insulin injections may soon be a thing of the past if Mannkind Corp.'s inhalable insulin product, Afrezza, is approved by ...
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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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Medac Pharma Has Reported FDA Acceptance of a NDA for Its Lead Product Candidate
Feb 7, 2014US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
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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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US FDA Granted Final Approval for The Company's Abbreviated New Drug Application
Jan 23, 2014Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Bromfenac ...
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MHLW Has Approved Takeda Pharmaceutical's NDA of Adcetris 50mg Intended to Treat Patients
Jan 21, 2014The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Adcetris (brentuximab vedotin) 50mg intended to treat patients with CD30 positive relapsed or refractory hodgkin ...
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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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Seattle Genetics Has Received Approval of ADCETRIS
Jan 18, 2014Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
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The U.S. Food and Drug Administration (FDA) Has Approved The New Drug Application
Jan 17, 2014Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PENNSAID® (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal ...
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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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Mylan Announced That Its U.S. Has Launched Mycophenolic Acid Delayed-Release Tablets
Jan 10, 2014Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® ...
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Actavis Plc Has Received Approval From The U.S. FDA on ANDA
Jan 10, 2014Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a ...
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Veloxis Pharmaceuticals Comprised 25 Studies and Enrolled Over 1000 Patients
Jan 2, 2014Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly ...
Tags: Veloxis Pharmaceuticals, New Drug Application, Envarsus®
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