Biopharmaceutical company Amarin has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for the marketing and sale of its Vascepa(R) (icosapent ethyl) capsules. Vascepa is ...
Tags: Amarin, Vascepa Capsule, FDA
Food and Drug Administration (FDA) has approved US-based pharmaceutical company Shionogi's Osphena (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy ...
Tags: FDA, Dyspareunia, Medicine
Mylan Pharmaceuticals, a subsidiary of global pharmaceutical company Mylan, has launched Fenofibrate Capsules USP, 43 mg and 130 mg. Fenofibrate Capsules, which are generic equivalent to Lupin Atlantis Holdings' Antara Capsules, are ...
Tags: Mylan Pharmaceuticals, Fenofibrate Capsules, pharmaceutical company
Medtronic has gained US marketing rights for new sizes of its Resolute Integrity drug-eluting stent, following the regulatory approval from the Food and Drug Administration (FDA). Available in 34mm, 38mm lengths and 3.0mm, 3.5mm and 4.0mm ...
US-based King Arthur Flour is voluntary recalling certain bags of flour as they may contain small blue polyurethane balls that are used in the sifting process, according to the Food and Drug Administration (FDA). The products subject ...
Tags: King Arthur Flour, bags of flour, FDA
Today, chocolates, chocolate bars and a variety of pralines are manufactured industrially. Nevertheless, the process of making chocolate demands considerable know-how and can only be carried out efficiently using modern systems. Innovative ...
Tags: manufactured industrially, double screw pump, screw pump
The USFDA has granted orphan drug designation to Pluristem Therapeutics' PLacental eXpanded (PLX) cells to treat aplastic anemia. The failure of hematopoietic stem cells (HSCs) present in the bone marrow to produce red blood cells, white ...
Tags: orphan drug, aplastic anemia, drug
Lupin Pharmaceuticals has obtained FDA approval for Suprax (Cefixime) for oral suspension, 500 mg/5mL and anticipates initiating product shipment shortly. Suprax oral suspension is indicated for otitis media, acute exacerbation of chronic ...
Tags: Lupin Pharmaceuticals, FDA, Suprax
Food Safety Tech, the organisers of Food Labs Conference, which will be held in conjunction with Pittcon 2013, March 19-20, at the Pennsylvania Convention Centre, Philadelphia, PA, announces the agenda of speakers for the two-day event. ...
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to SOV Therapeutics' oral testosterone undecanoate, a pro-drug of testosterone, for the treatment of Constitutional Delay of Growth and Puberty (CDGP) in ...
Tags: orphan drug, oral testosterone replacement therapy, FDA
Imprimis Pharmaceuticals has announced the completion of clinical trials of Impracor, a topical analgesic cream, which delivers a therapeutic dose of the pain-relieving, anti-inflammatory drug ketoprofen. The study, which was conducted by ...
Galderma Laboratories has gained US marketing rights for its Epiduo (adapalene 0.1%/BPO 2.5%) Gel, designed for the treatment of acne in children as young as nine years old, following the approval from the US Food and Drug Administration ...
The US Food and Drug Administration (FDA) has accepted to review Sanofi's new drug application (NDA) of lixisenatide, a once-daily a glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of adults with type 2 diabetes ...
US-based Advanta Supplements has unveiled Amazing Omega 3, a fish oil supplement which has been made with a proprietary, patented deodorization technology. Amazing Omega 3 fish oil supplement eliminates the aftertaste, smell, belching, ...
Tags: Advanta Supplements, Amazing Omega 3, fish oil supplement
Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia have approved ElectroCore's non-invasive, non-pharmaceutical vagus nerve stimulation ...
Tags: ElectroCore, Therapeutic Goods, Medicine