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Last updated on April 18, 2014 at 15:19 EDT

Latest Food and Drug Administration Stories

2014-03-24 23:01:38

The Firm is investigating Tylenol lawsuits on behalf of individuals who allegedly suffered liver damage from acetaminophen, the active ingredient in Tylenol-brand over-the-counter medications. New York, New York (PRWEB) March 24, 2014 As Tylenol lawsuits (http://www.tylenollawsuitclaims.com/) continue to mount in federal court, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has launched a review of the regulations governing over-the-counter medications,...

2014-03-24 12:31:14

PITTSBURGH, March 24, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist® (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court...

2014-03-24 12:30:14

MUMBAI, March 24, 2014 /PRNewswire/ -- Bharat Book Bureau presents Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations. China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs...

2014-03-24 08:29:56

Pivotal pharmacokinetic bridging clinical study anticipated to begin in May MALVERN, Pa., March 24, 2014 /PRNewswire/ -- Scilex Pharmaceuticals, Inc., a company engaged in the development and commercialization of products for the treatment of pain, today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration for its first product Ztilido(TM) (lidocaine patch 1.8%). The FDA Division of Anesthesia and Analgesia Products...

2014-03-24 08:28:09

Committee to Review Respiratory Safety Data Comparing Moxduo with Components SYDNEY and BEDMINSTER, N.J., March 24, 2014 /PRNewswire-USNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United States Food and Drug Administration (FDA) has set 22 April 2014 as the date of the Advisory Committee meeting to consider the Company's resubmitted Moxduo( )New Drug Application (NDA). "As previously announced, our PDUFA date is 25 May, 2014," said Dr. John...

2014-03-23 23:01:59

Federal Judge Overseeing More than 2,300 Pradaxa Lawsuits Schedules Four Bellwether Trials, First of Which Will Begin in September 2014. Columbus, OH (PRWEB) March 23, 2014 The federal judge overseeing thousands of Pradaxa lawsuits in the U.S. District Court, Southern District of Illinois, has established new dates for the litigation’s first bellwether trials, Wright & Schulte LLC reports. According to a Pretrial Order issued on March 5, 2014, by U.S. District Judge David Herndon,...

2014-03-22 23:02:37

The Firm is currently offering free and confidential Byetta lawsuit evaluations to individuals who may have developed pancreatic cancer, pancreatitis or thyroid cancer after taking the Type 2 diabetes medication. New York, NY (PRWEB) March 22, 2014 A year after the U.S. Food and Drug Administration (FDA) publicly vowed to investigate the safety of a drug now involved in Byetta lawsuit (http://www.byettalawsuit.com/) filings, as well as several other Type 2 diabetes medications, court...

2014-03-22 12:21:28

DALLAS, March 22, 2014 /PRNewswire/ -- ReportsnReports.com offers "Global Orphan Drug Market Outlook 2018", "Global Orphan Drugs Market 2014-2018" and "Global Orphan Drug Pipeline Analysis" research reports in its store. The returns on investment from orphan drugs are expected to help the pharma companies to overcome the impact of revenue loss due to expiry of patents of blockbuster drugs. The major drivers for companies to increasingly invest in orphan drugs include...

2014-03-21 23:26:05

To survive in today's tough economy and ultra-competitive medical device market, manufacturers need a quality system that works from the get-go. Medical Device Quality & Compliance Institute 2014: Quality Systems and Design Control Training is three-and-a-half days of intensive training on compliance guidance and insight needed to meet FDA standards with confidence. Falls Church, VA (PRWEB) March 21, 2014 Medical Device Quality & Compliance Institute 2014: Quality Systems and...

2014-03-21 16:23:29

NEW YORK, March 21, 2014 /PRNewswire/ -- Pomerantz LLP has filed a class action lawsuit against The Medicines Company ("Medicines" or the "Company") (NASDAQ: MDCO) and certain of its officers. The class action, filed in United States District Court, District of New Jersey, and docketed under 2:33-av-00001, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired Medicines securities between February 20, 2013 and February 12, 2014 both dates...


Latest Food and Drug Administration Reference Libraries

Flavr Savr
2013-10-03 09:43:32

Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...

Chilean Sea Bass, Dissostichus eleginoides
2013-01-12 08:49:28

The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...

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