Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
The FDA has approved Clinigen Healthcare's supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes. Hospira will distribute Foscavir to US ...
XenoPort has received a US patent for, prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use. The patent is directed to composition and formulations of the XP23829 compound and another patent ...
Tags: XenoPort, US patent, covering composition
AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) for intravenous (IV) use of Feraheme injection, to FDA. The company is seeking approval for the label expansion of Feraheme to include all iron deficiency ...
Tags: Feraheme Injection, AMAG, SNDA
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin. Mylan has commenced shipping the generic ...
Tags: FDA, Capsules Anda, Mylan Pharmaceutical, Medicine
Antares Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Otrexup, a combination product to deliver methotrexate methotrexate (MTX) using Medi-Jet technology. Antares Pharma president ...
Tags: NDA, FDA, medical technology
Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application
Pfizer 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
Eisai's Aciphex (rabreprazole sodium) has met the FDA's Written Request requirements for pediatric exclusivity in US. Having met FDA's requirement, the company has now gained an additional 6 months US market exclusivity for Aciphex, which ...
Tags: rabreprazole sodium, FDA, Aciphex, pediatric drug, GERD Drug
Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. ...
Takeda 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
Astellas Pharma US is seeking FDA approval for Tarceva tablets to treat non-small cell lung cancer patients (NSCLC) with tumors containing epidermal growth factor receptor (EGFR) that triggers mutations. The company submitted a ...
US 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
Horizon Pharma has commercially launched Rayos (prednisone) delayed release tablets in the US. Rayos is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma ...
Tags: Horizon Pharma, Rayos, rheumatoid arthritis