US based Watson Pharmaceuticals has filed a legal case against US Food and Drug Administration's (FDA) decision regarding the company's exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets). ...
Tags: Watson Pharmaceuticals, Actos, Pioglitazone Hydrochloride
Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild is a complete once-daily single tablet ...
Food service disposables and food packaging producer Pactiv has introduced the new EarthChoice 25 Percent Post Consumer Recycled Content Foam Foodservice packaging products for disposable food service needs. According to the US-based ...
Tags: Foodservice Packaging Containers, Containers, Foodservice Packaging
Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate. Xeljanz can be used as a single treatment regime or as ...
Tags: Pfizer, tofacitinib citrate, Xeljanz
Pfizer is voluntarily recalling its cough syrup medicine, Robitussin DM product, due to errors in its labeling, according to the US FDA . Robitussin DM product contains Dextromethorphan HBr 15mg and Guaifenessin 100mg per 5ml. ...
Johnson & Johnson has recalled K-Y Liquibeads vaginal lubricant from the market as US FDA insisted on additional approval for the product. The letter was issued in late May based on inspections conducted in December and January, ...
Tags: FDA, Johnson&Johnson, recall, lubricant product
Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA. The bovine anti-tumor necrosis factor polyclonal antibody is based on ...
Tags: Avaxia, Ulcerative Colitis Therapy, IND
The US FDA has approved Novo Nordisk Victoza (liraglutide [rDNA] injection) label to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin). Label update also includes approval of ...
Tags: Label update, type 2 diabetes, Victoza
Wockhardt has received final approval from the US Food and Drug Administration ((FDA) to market extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used to treat hypertension. Felodipine is the generic name for ...
Teva Pharmaceutical has received US Food and Drug Administration(FDA)approval for Synribo injection to treat adult patients with chronic phase(CP)or accelerated phase(AP)chronic myeloid leukemia(CML)with resistance and/or intolerance to ...
Tags: Teva Synribo Injection, US FDA, Teva Pharmaceutical, chronic phase
The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a CE mark for the expanded clinical indication for Harvest Technologies' SmartPReP 2 Bone Marrow Aspiration Concentration System (BMAC ...
Whole Alternatives is recalling six ounce packages of Harris Teeter brand dried apricots and eight ounce packages of dried golden raisins as they contain sulphur dioxide that is not mentioned on the ingredients label, according to the US ...
Tags: Whole Alternatives, recalling, six ounce packages, dried apricots
The US FDA has granted fast track review to Glenveigh Medical’s Digoxin Immune Fab (DIF), which is being developed as severe preeclampsia therapy. Glenveigh Medical founder and chairman Dr. David Adair said DIF is taking ...
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...