Generics Industry News Search
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March 2013 News Archive |
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Actavis today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone gel 10mg/0.5g...
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Indian generics maker bumps its offer to $500 million...
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Sun Pharmaceutical urged a district of Columbia federal judge Friday to block the U.S. Food and Drug Administration from approving any generic versions of the oncology drug Zometa until the agency decides whether to grant 180-day market exclusivity to the Indian drugmaker...
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Eli Lilly sued Roche's Genentech unit, asking a court to invalidate patents used to make treatments for cancer and autoimmune diseases and order that its Erbitux drug doesn't infringe the patent...
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India's patent appeals body Monday rejected Bayer's plea to stop a local company from manufacturing and selling a generic version of its cancer medicine Nexavar...
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Teva today announced the publication of results of the Phase III clinical trial of Milprosa (Progesterone) vaginal ring in Fertility and Sterility...
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Navamedic, the Norwegian pharmaceutical products company, today announced the launch of a new generic pharmaceutical product...
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Myriad Genetics's Australian court victory recognising its ownership of patents for genes linked to cancer risks will be appealed by a group representing cancer patients, a law firm said...
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AstraZeneca today announced that the Federal Court of Australia has found three patents protecting Crestor (Rosuvastatin) to be invalid...
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A patent appeals board upheld on Monday a decision to allow a domestic company to sell a generic version of Bayer AG's cancer drug Nexavar, in a blow for global drug maker's efforts to hold on to monopolies on high-price medicines...
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Ms. Bartlett, who lives in Plaistow, N.H., developed a rare but severe reaction to the anti-inflammatory drug Sulindac after a doctor prescribed it to treat shoulder pain in 2004...
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U.S. regulators granted Pfizer a reissued patent on its multibillion-dollar Celebrex pain drug that extends its marketing exclusivity until early December 2015, the company said on Tuesday...
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Dr. Reddy's laboratories announced today that it has launched Zoledronic Acid Injection, a bioequivalent generic version of Zometa Injection in the US market...
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Ranbaxy enters into an in-licensing business agreement with Alembic...
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Actavis has launched Montelukast tablets immediately after patent expiry in Denmark, France, Germany, Ireland, Italy, the Netherlands, Slovenia, Spain, Sweden and the UK...
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Generic drugs have dramatically changed the pharmaceutical and health-care landscape in the last 25 years and now account for about 80 percent of prescriptions in the United States, with lower prices for consumers and insurers...
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Actavis today confirmed that it has filed with the U.S. Food and Drug Administration (FDA) an amendment to its Abbreviated New Drug Application (ANDA) for Rivastigmine transdermal system to include the 13.3 mg per 24 hours dosage strength...
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InnoPharma today announced the launch of Cidofovir injection (generic equivalent of Vistide) in 5mL single-use vials...
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In a setback for plaintiffs seeking to bring a class action against the maker of a generic form of Lipitor found to contain tiny glass particles, a New Jersey federal judge has ruled that Ranbaxy Pharmaceuticals does not have to broaden its voluntary retail-only recall of the anti-cholesterol pills...
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Generic versions of popular pain relievers must be made harder to abuse, Attorney General Jack Conway and 47 other state and territorial Attorneys General told federal officials in a letter sent today by the National Association of Attorneys General (NAAG)...
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Merck and Bristol-Myers Squibb fired off patent infringement allegations in New Jersey federal court Thursday over Hetero Labs's plans to make a generic version of the HIV treatment Sustiva...
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Generic drug makers may get a boost now that the US Supreme Court has agreed to allow the Solicitor General to argue that federal law preempts personal injury lawsuits claiming design defects from proceeding in state courts...
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Brand and generic drug companies are usually at each other's throats...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has entered into a settlement agreement with Shionogi and Andrx that will resolve patent litigation related to Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg...
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Drug shortages have wreaked havoc on hospitals and drugstores over the past couple of years...
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Par Pharmaceutical today announced that it has received final approval from the U.S. FDA for its Abbreviated New Drug Application for fluvoxamine maleate 100 mg and 150 mg extended-release capsules...
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A comprehensive agreement between 29 multinational drug companies and Interpol to combat fake drugs has sounded the alarm bells among local drug-makers...
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A unit of Bayer, Germany's largest drugmaker, sued India's Glenmark seeking to stop sales of a generic form of its Finacea gel used to treat rosacea...
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Rep says Congress didn't intend to shield generics makers; Apotex fights with FTC against pay-for-delay...
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Perrigo today announced that it has begun shipments of Guaifenesin 600mg extended-release tablets in a launch to its retail and wholesale customers...
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Mylan today announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. FDA for its ANDA for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate)...
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The Supreme Court on Tuesday heard a generic-drug maker's argument that it should escape liability for selling a defective medication that left a New Hampshire woman disfigured, legally blind and unable to swallow food...
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Biogen, the fourth- largest U.S. biotechnology company by market value, won a U.S. patent that may guard its experimental multiple sclerosis pill from generic competition for eight more years than anticipated...
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Teva said it plans to control distribution of the anesthetic Propofol to prevent the drug from being used in executions of U.S. prisoners...
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Pharma major, Lupin, announced today that its subsidiary has received final approval for its Valsartan and Hydrochlorothiazide...
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Aurobindo said it had received final approvals from the US FDA to manufacture and market Valsartan and Hydrochlorothiazide...
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The feds should ensure an upcoming generic version of Oxycodone is harder to snort, a top New York lawmaker said Sunday...
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The Concept Foundation, an international non-governmental and not-for-profit organisation, has formed a new coalition of companies producing generic reproductive health supplies...
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Actavis, a leading specialty pharmaceutical company, today announced that is has reached a settlement agreement with AstraZeneca resolving outstanding patent litigation related to Actavis' generic version of Rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of Crestor tablets, as well as Actavis' Rosuvastatin zinc alternate salt product...
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The FTA might enable seizure of property of generic drug makers on suspicion of IP rights infringement...
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Mallinckrodt, the Pharmaceuticals business of Covidien, today announced that it launched the 36 and 54 milligram (mg) dosage strengths of Methylphenidate HCl extended-release (ER) tablets USP (CII), generic version of Concerta...
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The preclinical contract research organisation Absorption Systems, a global leader in pharmacokinetic testing of drugs and the world leader in the in-vitro classification of drugs according to the Biopharmaceutics Classification System (BCS), announces that it has registered with the United States Food and Drug Administration (FDA) as a generic drug facility under the Generic Drug User Fee Amendments of 2012 (GDUFA)...
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The University of Pennsylvania sued St. Jude Children's research hospital over a patent for creating genetically modified versions of immune cells to treat cancer...
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Several Supreme Court justices expressed skepticism on Monday about the legality of payments by brand-name drug companies to potential generic competitors in exchange for keeping their cheaper, rival drugs off the market...
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Breckenridge announced today that it has entered into an agreement with Aptalis to market Propranolol hydrochloride extended-release capsules USP, the generic version of Inderal LA by Akrimax, under Aptalis's Abbreviated New Drug Application (ANDA)...
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Drug firm BDR Pharma has applied for a compulsory licence to market generic version of US-based Bristol-Myers Squibb's cancer drug Dasatinib, sold under 'Sprycel' brand, promising to offer the product at price cheaper by over 95 per cent for a month's treatment...
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BD, a leading global medical technology company, todayannounced that the U.S. FDA has approved the first drug to be offered in the just-launched BD Simplist ready-to-administer, line of prefilled generic injectables...
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The lifting of the import alert by the US FDA at the manufacturing unit VI of Hyderabad-based Aurobindo led to the drug company's stock closing 11.7% higher today. This is a significant upside move for the stock, which has depreciated over 30% since the beginning of 2013...
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Dr. Reddy's Laboratories announced today that it has launched Zenatane (Isotretinoin capsules USP) in 20 mg and 40 mg, a therapeutically equivalent generic version of Accutane (Isotretinoin capsules USP)...
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Teva today announced that the U.S. Food and Drug Administration has approved Quartette (Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol) tablets for the prevention of pregnancy...
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Swiss specialty chemicals and life sciences group Lonza is reviewing whether it is still worth investing in its joint venture with Teva in "biosimilar" drugs, its Chief Executive said...
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