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- Read more about Gilead submit US FDA approval for Fixed-Dose Combination of emtricitabine/tenofovir alafenamide for HIV treatment
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.
- Read more about Oncolytics REOLYSIN seeks US FDA orphan drug status to treat gastric cancer
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.
- Read more about FDA ordered strict warning for anemia drug Feraheme
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.
- Read more about FDA approves breath test for treatment of gastroparesis
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.
- Read more about Glenmark receives US FDA approval for norethindrone acetate and ethinyl estradiol tablets USP
Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics, has received the final approval from the United States Food and Drug Administration (USFDA) for sale of drugs meant to prevent post-menopause osteoporosis.USFDA granted Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg.
- Read more about VenaSeal Closure System got approval by FDA
The US Food and Drug Administration (FDA) has approved the VenaSeal closure system, first device to permanently treat varicose veins of leg by sealing them with an adhesive agent. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.
- Read more about FDA targets opioid drug abuse by issuing guidelines to manufacturers
The US Food and Drug Administration (FDA) issued guidelines to manufacturing industry which will help manufacturers develop abuse-deterrent opioid drugs.
- Read more about Daiichi Sankyo's “Savaysa” got approval from FDA
The U.S. Food and Drug Administration granted approval to Savaysa (edoxaban tablets) as anticlotting drug. This drug is used to reduce dangerous blood clots in patients with atrial fibrillation, deep vein thrombosis and pulmonary embolism.
- Read more about Strict regulations on India’s Food And Drug Firms: FDA
The Food and Drug Administration (FDA) is insisting the regulations in this regard are strictly followed. This ensures the products that come into the US are of the highest quality, have safety built into them and are effective. The US Food and Drug Administration (FDA) is increasing the frequency of inspections in India.
- Read more about Novo Nordisk to launch Novoeight® in the United States for People With Hemophilia A
Novo Nordisk today announced the company will launch Novoeight^®(Antihemophilic Factor [Recombinant]) in the United States for people living with hemophilia A. Novoeight^® offers purity, reliability, and enhanced portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products—up to 86 degrees F for 12 months. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time. Novoeight^® offers purity through a 5-step purification process. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A. Novo Nordisk plans to make Novoeight^® available by mid-April 2015.