The U.S. Food and Drug Administration allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
Perrigo Company plc, received US Food and Drug Administration (FDA) approval for the generic version of Valeant Pharmaceutical International Inc's BenzaClin topical gel.
U.S. Food and Drug Administration (FDA) has accepted BMS's filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate -067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016.
US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).
A panel of experts from the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure® permanent birth control. While there was agreement among the Panel members that Essure is an important contraceptive option, the Panel provided input and guidance for the FDA and Bayer to consider. Based on information presented during this meeting, the Advisory Panel discussed a number of considerations including clinical research, patient education and counseling. The Panel also discussed training and certification of physicians; and post-procedural patient management including removal of the device.
Jubilant Life Sciences Ltd, an integrated global pharmaceuticals company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (FDA) for zolmitriptan orally disintegrating tablets, 2.5 mg and 5 mg the generic version of Zomig-ZMT (AstraZeneca), which is used for acute treatment of migraine headaches in adults.
Granules India, a Rs. 1,200 crore pharmaceutical major from Hyderabad, has received US FDA approval for ibuprofen tablets USP, 400 mg, 600 mg and 800 mg.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for voriconazole tablets, 50 mg and 200 mg of PF Prism C.V. (Prism).
The US Food and Drug Administration (USFDA) has approved Aurobindo Pharma to market generic version of Prilosec delayed-release capsules used to treat ulcer.