Actavis has resolved outstanding patent litigation concerning generic version of Intuniv (guanfacine hydrochloride), indicated for the treatment of attention deficit hyperactivity disorder, with Shire. The settlement agreement also ...
Cosmetics (colloquially known as makeup or make-up) are care substances used to enhance the appearance or odor of the human body. They are generally mixtures of chemical compounds, some being derived from natural sources, many being ...
Tags: Cosmetics, History, cosmetics derives
Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA). The PMA application shell accepted by the FDA for the ...
Andrew Technologies has obtained 510 (k) clearance from the US Food and Drug Administration (FDA) for its Autologous Fat Transfer device. The liposuction device, which is based on Tissue Liquefaction Technology, reinjects the adipose ...
Teva Pharmaceutical and Xenon Pharmaceuticals have announced the FDA orphan drug designation for analgesic XEN402 being developed to treat pain associated with erythromelalgia (EM). The novel chemical entity XEN402 is designed to inhibit ...
Tags: Pharmaceutical, FDA, Orphan Drug
Cortec has launched its newly reformulated, recyclable Cor-Pak VpCI Stretch Film, which provides corrosion protection solution for primary packaging and unitization. Produced by the company and its European Subsidiary EcoCortec, the ...
Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/23/2013 5:04:22 PM The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride ...
InspireMD has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to initiate MASTER II clinical study of its MGuard embolic protection stent (EPS). The CE-marked ...
Tags: InspireMD, Protection Stent Study
The US Food and Drug Administration (FDA) has approved BD Rx's second injectable antiemetic, BD Simplist Metoclopramide Injection, USP. BD Simplist prefilled injectables are designed to enhance patient care and safety by minimizing the ...
BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test. The application included positive ...
Tags: Biofire, FDA Clearance
The US Food and Drug Administration (FDA) has approved Warner Chilcott's new oral contraceptive MINASTRIN 24 FE. MINASTRIN 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is indicated for use by ...
The USFDA has approved Amarin supplemental new drug application for Chemport as additional Vascepa active pharmaceutical ingredient supplier. The approval adds to the company's planned expansion of the Vascepa manufacturing supply chain ...
The US-based CAS Medical Systems (CASMED) has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation Fore-Sight Elite Absolute Tissue Oximeter. The Fore-Sight ELITE Oximeter, which is capable of ...
Tags: Casmed, Absolute Tissue Oximeter
Prime Food USA is recalling Latis brand Herring Fillet 'Matiej', Salmon Fillet Slices and Herring Fillet 'Forelka' in oil due to listeria monocytogenes contamination, according to the US Food and Drug Administration (FDA). The products ...
Tags: Prime Food, Listeria Contamination
The University of Texas MD Anderson Cancer Center in Houston, US, has purchased Elekta's two radiation therapy systems. Equipped with the Agility multileaf collimator, Versa HD linear accelerators provide high-speed, high-precision beam ...
Tags: MD Anderson Cancer Center, Elekta Versa HD Linear Accelerators