Tag food and drug administration fda

Photo Release FDA Approves Lip Indication for Medicis’ Restylane(R)

Oct11

SCOTTSDALE, Ariz., Oct. 11, 2011 (GLOBE NEWSWIRE) Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement to expand the approved use of RESTYLANE Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE was previously approved to treat moderate to severe facial […]

Banner Announces Submission of Its First-to-File ANDA for Targretin

Oct10

Expects to qualify for 180 days of generic marketing exclusivity HIGH POINT, N.C.(BUSINESS WIRE) Banner Pharmacaps Inc. (Banner?) has confirmed that its Abbreviated New Drug Application (ANDA?) for Bexarotene 75 mg soft gelatin capsules, a generic version of Targretin, has been accepted for review by the US Food and Drug Administration (FDA). Based upon available […]

FDA Releases ‘Use Medicines Wisely’ PSA

Oct1

SILVER SPRING, Md., Oct. 1, 2011 /PRNewswire/ The U.S. Food and Drug Administration (FDA) Office of Women's Health today released a new public service announcement (PSA) titled, "Use Medicines Wisely," to help raise awareness about safe medication use.To view the multimedia assets associated with this release, go to: http://multivu.prnewswire.com/mnr/fda/50878/ Millions of people benefit from FDA […]

MultiVu Video: Please Help Raise Awareness About Safe Medication Use By Airing the Enclosed PSA From The U.S. Food and Drug Administration (FDA)

Oct1

ADDITIONAL RESOURCES: Video, downloadable MPEG4, contact information and more available at SUMMARY:Millions of people benefit from FDA approved medications and are living longer productive lives. However, when medications are used incorrectly, they can cause serious injuries even death. Many of these injuries can be prevented. Did you know that…?About half of people who use medicines […]

Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products; Availability

Sep29

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Time and Extent Applications for Nonprescription Drug Products." This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. The process includes submitting a time and […]

Research and Markets: United States Pharmaceuticals and Healthcare Report Q4 2011

Sep20

DUBLIN(BUSINESS WIRE) Research and has announced the addition of the “United States Pharmaceuticals and Healthcare Report Q4 2011″ report to their offering. Business Monitor International’s (BMI) United States Pharmaceuticals and Healthcare Report (Q4 2011) provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on […]

USP -Quality of OTC Medicines, Ingredients Critical to Patients; Modern Scientific Standards Needed to Support Globalized Industry

Sep14

ENP Newswire – 14 September 2011Release date- 13092011 – Top officials from the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and the U.S. Pharmacopeial Convention (USP) expressed the need for modern scientific standards to help ensure the quality of over-the-counter (OTC) monograph medicines and their ingredients at a workshop, September 8-9.Widely relied upon […]

Quality of OTC Medicines, Ingredients Critical to Patients; Modern Scientific Standards Needed to Support Globalized Industry

Sep13

Rockville, Md. (PRWEB) September 13, 2011Top officials from the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and the U.S. Pharmacopeial Convention (USP) expressed the need for modern scientific standards to help ensure the quality of over-the-counter (OTC) monograph medicines and their ingredients at a workshop, September 8-9. Widely relied upon by consumers every […]

European Fine Chemicals Group Ratifies FDA’s Proposed Generic Drug User Fees Act (GDUFA)

Sep10

BRUSSELS, September 10, 2011 /PRNewswire/ The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law […]

European Fine Chemicals Group Ratifies FDA’s Proposed Generic Drug User Fees Act (GDUFA)

Sep9

BRUSSELS, September 9, 2011 /PRNewswire/ The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law […]