Tag U.S. Food

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 […]

Watson Confirms EMBEDA(R) Patent Challenge

Oct7

PARSIPPANY, N.J., Oct. 7, 2011 /PRNewswire/ Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 […]

FDA: Over-the-Counter Asthma Inhalers Containing Chloroflouorocarbons CFCs Will No Longer Be Made or Sold After Dec. 31, 2011

Oct6

The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary […]

Mylan Applauds Study Highlighting $931 Billion in Savings for U.S. Health Care System Due to Generic Drugs

Oct5

Mylan Inc. (Nasdaq: MYL) today applauded a new study released by the Generic Pharmaceutical Association (GPhA) as further evidence of the savings and access that high quality, cost effective generic prescription drugs can bring to American consumers (see also Mylan Inc.).According to the independent analysis of data conducted by IMS Health, the world’s leading provider […]

Guidance Now Available for Adding Products to OTC Drug Monograph System

Oct3

by VARALAKSHMI PULUGURTHATargeted News ServiceWASHINGTON, Oct. 3 The U.S. Food and Drug Administration has issued a notice of the availability of a guidance program for industry entitled "Time and Extent Applications for Nonprescription Drug Products," according to Policy Acting Assistant Commissioner Leslie Kux.A summary of a notice in the Federal Register states: "This guidance describes […]

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 […]

FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011; Users of Primatene Mist will need a prescription product to treat their asthma

Sep23

ENP Newswire – 23 September 2011Release date- 22092011 – The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene […]

FDA: Over-the-Counter Asthma Inhalers Containing Chloroflouorocarbons (CFCs) Will No Longer be Made or Sold After Dec. 31, 2011

Sep22

WASHINGTON, Sept. 22 The U.S. Department of Health and Human Services’ Food and Drug Administration issued the following news release:The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. […]

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 […]