Aurobindo Pharma has received the final approval from the US Food and Drug Administration to manufacture and market Atracurium Besylate injection in single and multi-dose vials in the US market.
Ethicon, a part of J&J, received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation. It retains its strength and stickiness while it’s still around. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients. EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis . The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.
Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical group active in global markets, announced that EU has approved its new room-temperature-stable formulation of Pabal (carbetocin) for intravenous (IV) administration.
Gilead Sciences has submitted a new drug application (NDA) to the FDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients aged 12 years and older, in combination with other HIV antiretroviral agents.
Novo Nordisk opens a new manufacturing facility in Russia for formulation and filling of modern insulin for the treatment of diabetes. The production will cover both Penfill® cartridges and FlexPen® prefilled insulin injection pens for the Russian market.
Oncolytics Biotech Inc., a biotechnology company concentrated on the development of oncolytic viruses as potential cancer therapeutics. Company has presented an application to the US Food and Drug Administration (FDA) for REOLYSIN to get Orphan Drug Designation for the treatment of gastric cancer.
Health ministry to amend Form 12-B of D&C Rules; Form 12-B of the Drugs and Cosmetics Rules is for giving permission for import of small quantities of drugs for personal use. The Union health ministry will soon amend Rules in this regard.
The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug “Feraheme”. It could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product. Health care professionals should strictly follow the recommendations mentioned in the drug label. Patients should immediately call doctor if there is breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.
Biocon Ltd, Asia's premier biopharmaceuticals company, announced that its Insulin Glargine has been approved by COFEPRIS, the Mexican health authority, through its partner PiSA Farmaceutica (PiSA).