Medication Guide App

Pharmaceutical Industry News

Get news by email or subscribe to our news feeds.

Mylan Launches Generic Lunesta Tablets

Posted yesterday in Pharma Industry News

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 million for...

Read more...

FDA Approves Merck’s Grastek as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis

Posted yesterday in Pharma Industry News

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro...

Read more...

FDA Develops Alternative Assay That Could Speed Availability of Pandemic Influenza Vaccines

Posted 6 days ago in Pharma Industry News

April 9, 2014 -- A laboratory assay developed by scientists at the U.S. Food and Drug Administration (FDA) could speed the release of pandemic influenza vaccines to the public by shortening the time it takes to test vaccine potency. The FDA scientists developed the new assay in response to the recommendation of a workshop organized by the World Health Organization (WHO) following the 2009 H1N1 influenza pandemic and an initiative by the U.S. Department of Health and Human Services’...

Read more...

Teva Announces First Approval and Launch of Generic Lovaza Capsules in the United States

Posted 6 days ago in Pharma Industry News

JERUSALEM--(BUSINESS WIRE)--Apr. 8, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Lovaza® (Omega-3-Acid Ethyl Esters Capsules, USP), in the United States. Teva believes it is first-to-file and thus far is the only Company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza® Capsules, marketed by GlaxoSmithKline, had annual sales of approximately $1.1 billion in the United States, according to IMS...

Read more...

Zogenix Takes Legal Action in Federal Court to Block Massachusetts Improper Ban on Zohydro ER

Posted 8 days ago in Pharma Industry News

SAN DIEGO, April 7, 2014 /PRNewswire/ -- Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today filed a lawsuit in the U.S. District Court in Massachusetts requesting the court to grant a temporary restraining order against execution of the executive order recently announced by Governor Deval Patrick, which prohibits the prescribing and dispensing of the Company's...

Read more...

FDA Warns Consumers Not To Use Zi Xiu Tang Bee Pollen Capsules

Posted 8 days ago in Pharma Industry News

April 7, 2014 -- The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. All products that have been tested, including those that claim to be...

Read more...

Monthly News Roundup - March 2014

Posted 2 weeks ago in Pharma Industry News

Biogen Idec’s Orphan Drug Alprolix Approved for Hemophilia B Hemophilia B is an inherited sex-linked, blood-clotting disorder, which primarily affects males, and is caused by defects in the Factor IX gene. The U.S. Food and Drug Administration (FDA) has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require fewer injections. Alprolix consists of the Factor IX molecule, but it’s...

Read more...

GSK reports alli® product tampering, alerts consumers to unknown product in alli® packages

Posted 2 weeks ago in Pharma Industry News

(Moon Township, PA) - March 26, 2014 — GlaxoSmithKline (GSK) is alerting consumers that some bottles of its alli® over-the-counter weight loss medication have been tampered with. Consumer safety is GSK’s primary concern. We have initiated an investigation and are working with the Food and Drug Administration. What does the tampered product look like: The outer carton may look authentic. The bottle may contain a range of tablets and capsules of various shapes and colors. The bottle may...

Read more...

Actavis and Valeant Announce FDA Approval for Metronidazole 1.3%

Posted 3 weeks ago in Pharma Industry News

DUBLIN and LAVAL, Quebec, March 25, 2014 /PRNewswire/ -- Actavis plc and Valeant Pharmaceuticals International, Inc today announced that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV). Actavis acquired the rights to Metronidazole 1.3% from Valeant Pharmaceuticals International in April 2013. Bacterial vaginosis is an infection caused by an imbalance in the...

Read more...

Pfizer Will Appeal Court Decision Regarding Celebrex Reissue Patent

Posted 4 weeks ago in Pharma Industry News

Wednesday, March 12, 2014 - 2:18pm EDT - Pfizer Inc. confirmed today that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (U.S. Patent No. RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. Pfizer disagrees with the ruling and will pursue all available remedies, including an immediate appeal of the court’s decision. A...

Read more...

FDA Approves Label Changes for Doribax (doripenem)

Posted 5 weeks ago in Pharma Industry News

March 6, 2014 - The U.S. Food and Drug Administration (FDA) has concluded that Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety...

Read more...

Teva Announces Approval of Generic Evista Tablets

Posted 5 weeks ago in Pharma Industry News

JERUSALEM--(BUSINESS WIRE)--Mar. 4, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Evista (raloxifene) Tablets, 60 mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Teva will begin shipping the product within the next 30 days. Evista® 60 mg Tablets marketed by Eli Lilly and Company, had annual sales of approximately $824 million in the United States, according to...

Read more...

Monthly News Roundup - February 2014

Posted 6 weeks ago in Pharma Industry News

FDA Approves Amylin’s Myalept for Rare Metabolic Disease The U.S. Food and Drug Administration (FDA) has approved the orphan drug Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital or acquired generalized lipodystrophy. Patients with generalized lipodystrophy often develop severe insulin resistance, diabetes, or high levels of triglycerides (hypertriglyceridemia) that can lead to...

Read more...

FDA issues first orders to stop sale, distribution of tobacco products

Posted 7 weeks ago in Pharma Industry News

February 21, 2014 - The U.S. Food and Drug Administration issued orders today to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them. The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis...

Read more...

FDA and European Medicines Agency Strengthen Collaboration in Pharmacovigilance Area

Posted 7 weeks ago in Pharma Industry News

WEDNESDAY, Feb. 19, 2014 -- The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA...

Read more...

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

Posted 8 weeks ago in Pharma Industry News

February 18, 2014 -- The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected...

Read more...

Saliva Test May Spot Depression Risk in Male Teens

Posted 8 weeks ago in Pharma Industry News

A simple saliva test might one day spot which teenaged boys are most likely to develop major depression later in life, British researchers report. After testing both boys and girls who had been diagnosed with mild depression, the researchers found that boys with high levels of a stress hormone called cortisol were 14 times more likely to be diagnosed with clinical depression later, according to the Associated Press. Girls with high cortisol levels were only four times more likely to receive...

Read more...

Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the United States

Posted 8 weeks ago in Pharma Industry News

February 13, 2014 -- Two individuals today were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. The FDA led a joint international law enforcement operation that culminated...

Read more...

Drugs.com and TrialReach to Give Patients Access to Drugs In Development

Posted 9 weeks ago in Pharma Industry News

SAN FRANCISCO and LONDON, Feb. 5, 2014 - Drugs.com, the leading online clinical drug resource, and TrialReach are partnering to provide patients with information and access to treatments that are still under development. Announced today at Rock Health, this new partnership will bring TrialReach's patient-centric content and tools directly to the 25+ million people who visit Drugs.com every month. From a patient's perspective, clinical trials offer more treatment options when the standard...

Read more...

FDA Launches First National Public Education Campaign to Prevent, Reduce Youth Tobacco Use

Posted 10 weeks ago in Pharma Industry News

February 4, 2014 -- The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. “The Real Cost” campaign is the FDA’s first of several planned tobacco education campaigns using the new authority granted under the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009. Tobacco use remains the leading...

Read more...
Hide
(web1)