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FDA Acceptance
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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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Enteromedics Submitted Pma Application to US FDA for Maestro Rechargeable System's VBLOC
Jul 30, 2013EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
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Chelsea Therapeutics Has Announced The Us FDA Acceptance of Northera NDA Resubmission
Jul 22, 2013Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
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Iroko Has Announced The FDA Acceptance for New Drug Application
Jul 18, 2013Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
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FDA Acceptance of Biologics License Application Sublingual Allergy Immunotherapy Tablet
May 13, 2013Merck, referred to as MSD outside the US and Canada, has announced the FDA acceptance of biologics license application (BLA) of investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet for review. ...
Tags: Merck Biologics, Medicine
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BioDelivery and Arcion Have Signed a Worldwide Licensing Deal
Mar 28, 2013BioDelivery Sciences International and Arcion Therapeutics have signed a worldwide licensing deal for the development and commercialization of topical clonidine gel (previously ARC4558) to treat painful diabetic neuropathy (PDN) and other ...
Tags: BioDelivery, Arcion Therapeutics, topical clonidine gel development
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The BZA/CE Is an Investigational Therapy Developed by Wyeth Pharmaceuticals
Dec 17, 2012Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
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FDA Acceptance of Vortioxetine New Drug Application Filing for Major Depressive disorder
Dec 14, 2012Takeda Global Research & Development Center and Lundbeck have announced the FDA acceptance of vortioxetine new drug application (NDA) filing for major depressive disorder. The companies have also announced the proposal of Brintellix as ...
Tags: FDA, new drug application, NDA
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NDA Resubmission for Its Migraine Patch Has Been Accepted
Dec 14, 2012US based NuPathe announced that its New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the US Food and Drug Administration (FDA). Migraine Patch (NP101 or Zelrix) is an active, ...
Tags: FDA, NuPathe, migraine patch, NDA
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Teva Women's Health Has Announced FDA Acceptance of Its Quartette NDA
Dec 7, 2012Teva Women's Health, a US-based subsidiary of Teva Pharmaceutical Industries, has announced FDA acceptance of its Quartette new drug application (NDA). The company is seeking approval to manufacture and market Quartette ...
Tags: ethinyl estradiol tablets, market Quartette, contraceptive products
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Genzyme Submitted a New Drug Application to The FDA Seeking Approval for KYNAMRO
Dec 5, 2012Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
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AVEO Is Accepted by FDA
Nov 29, 2012AVEO Oncology and Astellas Pharma have announced FDA acceptance of tivozanib new drug application(NDA)filing for the treatment of advanced renal cell carcinoma(RCC). According to the development and commercialization deal signed between ...
Tags: AVEO Oncology, Astellas Pharma, FDA, RCC, NDA
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Nuvo Research's Compositions and Methods of Using Pennsaid 2.0% W/W
Sep 6, 2012The United States Patent Office has issued a patent covering Nuvo Research's compositions and methods of using Pennsaid (diclofenac sodium topical solution) 2.0% w/w (Pennsaid 2% Patent), which will expire on 21 April 2028. Pennsaid is a ...
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Raptor Pharmaceutical Has Announced FDA Acceptance of New Drug Application
Jun 14, 2012Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
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