USFDA

FDA permits marketing of new laser-based hearing aid with potential for broad sound amplification

  • Posted on: 2 October 2015
  • By: PharmaTutor News

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.

Perrigo receive US FDA approval for generic BenzaClin topical gel

  • Posted on: 29 September 2015
  • By: Shalini.Sharma

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 noded to BMS's sBLA for untreated advanced melanoma

  • Posted on: 26 September 2015
  • By: PharmaTutor News

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.

U.S. FDA Advisory Committee provides advice for continued safe and appropriate use of Essure® permanent birth control

  • Posted on: 25 September 2015
  • By: PharmaTutor News

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.

US FDA approve zolmitriptan ODT tablets of Jubilant Life

  • Posted on: 23 September 2015
  • By: Shalini.Sharma

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.

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