USFDA warns Aurobindo pharma
US health regulator sends a warning letter to Drug-maker Aurobindo Pharma with regard to its antibiotics manufacturing unit in Hyderabad.
Devices to Fight Obesity to Launch in 2011
Three new fat removal technologies that are awaiting approval from the US Food and Drug Administration should be available to patients by 2011.
DA Launches External Defibrillator Improvement Programme
The US Food and Drug Administration (FDA) has launched a programme to facilitate the development of safer and more effective external defibrillators through improved design and manufacturing practices.
Sun Pharma receives USFDA nod for generic Clarinex, Tiazac
The Mumbai-based firm has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) to market a generic version of Schering Plough’s Clarinex tablets, Sun Pharma said in a statement.
Sun gets USFDA nod for generic heart disease drug
Drug maker Sun Pharma recently said it has received a tentative approval from US health regulator to sell a generic version of Crestor tablets, used in the treatment of various heart diseases, in the American market.
FDA Issues Guidance to Infusion Pump Manufacturers
The US Food & Drug Administration (FDA) has issued new guidance and letters to infusion pump manufacturers as part of an initiative to institute stricter pre-market requirements.
New Complete SE Vascular Stent Receives FDA Approval
An SE vascular stent system has received approval from the US Food and Drug Administration to treat peripheral arterial disease in the iliac arteries and major blood vessels.
FDA to Overhaul Approval Process for Radiotherapy Devices
The US Food and Drug Administration (FDA) has taken steps to strengthen the approval process for radiotherapy devices following multiple errors. In a letter to the device manufacturers, the FDA identified issues from recent analysis of more than 1,000 reports of errors, which could be fixed by incorporating additional safeguards.
Wockhardt jumps on US FDA nod for generic drug
Wockhardt and Sun Pharmaceutical have received final approval from the United States Food and Drug Administration (USFDA) to market generic versions of Nicardipine, the hypertension drug.
Elder inks pact with Aussie firm
Mid-sized pharma firm Elder Pharmaceuticals has tied up with Australian pharma firm Global Energy Medicines (GEM) to market the latter
