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Last updated on April 20, 2014 at 21:20 EDT

Latest U.S. Food and Drug Administration Stories

2014-04-18 23:02:27

The Firm is actively filing GranuFlo lawsuits on behalf of dialysis patients who allegedly experienced sudden cardiac death, strokes, heart attacks and other devastating heart problems within 72 hours of receiving the medication. New York, NY (PRWEB) April 18, 2014 Bernstein Liebhard LLP has launched a new website for dialysis patients and families who were allegedly affected by the GranuFlo recall (http://www.granuflolawsuit2014.com/) of June 2012, and are now considering a claim against...

2014-04-17 08:28:00

RIDGEFIELD, Conn., April 17, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated in a Phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for intensive remission induction therapy....

2014-04-16 23:02:11

The Firm is actively filing GranuFlo recall lawsuits on behalf of individuals who allegedly suffered sudden cardiac death, heart attacks, strokes and other cardiovascular problems after use of this medication and NaturaLyte. New York, NY (PRWEB) April 16, 2014 Bernstein Liebhard LLP notes a significant increase in the number of cases filed since last month in a federal GranuFlo lawsuit (http://www.thegranuflolawsuit.com/ ) litigation underway in the District of Massachusetts, where more...

2014-04-15 23:01:01

The European Medicines Agency (EMA) is investigating the potential cardiovascular risks of testosterone therapies, according to a report in MedPage Today. In January, the U.S. Food and Drug Administration (FDA) also began investigating these products; both agencies launched their reviews due to two studies linking testosterone drugs to a higher risk of heart attack and other cardiovascular issues. New York, New York (PRWEB) April 15, 2014 Parker Waichman LLP, a national law firm dedicated...

2014-04-15 12:30:09

PITTSBURGH, April 15, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it and its partner Famy Care Ltd. have entered into a settlement and license agreement with Warner Chilcott Company, LLC, settling the parties' litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets 0.8 mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This...

2014-04-15 12:29:59

PITTSBURGH, April 15, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Eszopiclone Tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta(®). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of insomnia. Eszopiclone Tablets 1 mg, 2 mg, 3 mg had U.S. sales of approximately $851.8...

2014-04-11 08:24:52

SAN DIEGO, April 11, 2014 /PRNewswire/ -- Rampant misinformation about Zohydro(TM) ER continues to be reported by the media and echoed in Washington D.C. and some states' capitals. These inaccurate and misleading statements are often made without proper context, and are intended to be sensational, to create fear, or to generate headlines. In many instances, these statements are not supported by scientific facts or medical evidence. Let's get the facts straight Zohydro ER is the first and...

2014-04-11 08:24:31

PITTSBURGH, April 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5 mg. This product is the generic version of FROVA(®), which is used to treat acute...

2014-04-11 08:24:24

HAYWARD, Calif., April 11, 2014 /PRNewswire/ -- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease (PD). After discussions with the FDA, the Company has...

2014-04-09 12:31:44

WASHINGTON, April 9, 2014 /PRNewswire-iReach/ -- Parents of children facing death from Duchenne muscular dystrophy today asked the U.S. Food and Drug Administration to approve in 30 days a well-tested drug that halts the disease with no side effects. (Photo: http://photos.prnewswire.com/prnh/20140409/MN00963) The parents, representing The Race to Yes campaign, challenged FDA Commissioner Margaret Hamburg to take the steps needed to approve the drug - eteplirsen - following positive comments...