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
ETView Medical has obtained European pre-market clearance for Viva-EB line of endobronchial blockers. The Viva-EB product family are designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures ...
Tags: Viva-EB line of endobronchial blockers, clinical application, CE Mark
GeNO has obtained a clearance for its inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, from the US Food and Drug Administration (FDA). GeNOsyl MV-1000 system, which incorporates a primary delivery system, a backup system, ...
Tags: FDA, inhaled nitric oxide delivery system, clinical product, GeNO
GeNO has received four additional US patents for its proprietary nitric oxide (NO) generation chemistry and delivery technology. The patent No. 8,211,368 describes the conversion of nitrogen dioxide (NO2) to NO where NO2 is stored as ...
Tags: US patent, clinical technology, clinical research, GeNO
Rising Pharmaceuticals, a finished dosage form generics subsidiary of ACETO, has launched 500 mg strength (microsize) of Griseofulvin tablets, which are generic equivalent to Valeant Pharmaceutical's FDA approved Grifulvin. Griseofulvin ...
Tags: Tablet, Pharmaceuticals, Griseofulvin, FDA
Oculus Innovative Sciences has enrolled first patient, under an FDA-reviewed protocol, in a clinical study of its Microcyn hydrogel. Microcyn hydrogel is indicated for use in hypertrophic or keloid scars management. The double-blind, ...
Tags: Oculus Innovative Sciences, Microcyn hydrogel, keloid scars management
Forest Laboratories and Almirall have announced the commercial availability of anticholinergic agent Tudorza Pressair in 400mcg dose strength, in the US pharmacies. The FDA approved long-acting anticholinergic was indicated for the ...
Tags: anticholinergic agent, pharmacies, multidose, Almirall, medicine
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. ...
Medivation and Astellas Pharma have announced FDA approval for Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer in patients with previously received docetaxel. Medivation and Astellas expect to make ...
Tags: Medivation, Astellas, FDA
Precision Spine has gained US marketing rights for its minimally invasive spinal fixation system, following the Food and Drug Administration's (FDA) approval. The Mini-Max minimally invasive access system, which is designed for use with ...
Tags: US, FDA, Precision Spine
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
The US FDA has granted orphan drug designation to Milo Biotechnology's AAV1-FS344 to treat Becker and Duchenne muscular dystrophy. AAV1-FS344 is myostatin inhibitor delivered through gene therapy to increase muscle strength in patients. ...
Tags: FDA, orphan drug designation, US
Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy. The drug candidate is being studied to treat acquired hemophilia A ...
Tags: FDA, fast track status, drug candidate
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