Generics Industry News Search
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June 2011 News Archive |
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Pfizer, the world's biggest drugmaker, settled claims it had against Teva Pharmaceutical Industries over generic versions of the Neurontin epilepsy drug, ending a trial that was under way in federal court...
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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Piperacillin and Tazobactam for Injection, the number one prescribed intravenous antibiotic in the U.S. APP will launch the product immediately...
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N.J.-based ReGen Biologics, Inc. filed a lawsuit May 31 against the FDA, Commissioner Margaret A. Hamburg, and HHS Secretary Kathleen Sebelius, alleging that the agency's actions to rescind 510(k) clearance of the company's Menaflex Collagen Meniscus Implant were unlawful, arbitrary and capricious...
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Teva has received approval from the US Food and Drug Administration to sell a generic version of Alzheimer's drug, Aricept...
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Israeli generics giant Teva Pharmaceutical Industries announced yesterday that patent litigation with global drugs behemoth Pfizer related to generic versions of Pfizer's Neurontin (gabapentin) capsules and tablets sold by Teva and its subsidiary IVAX Pharmaceuticals has been dismissed by the US District Court for the District of New Jersey...
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Watson Pharmaceuticals confirmed that its subsidiary, Watson Laboratories filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market Sildenafil, a generic version of Pfizer's Viagra. Pfizer recently filed suit against Watson on June 1, 2011...
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Impax said Friday that it is seeking approval for a generic version of the overactive-bladder drug Detrol and is being sued by Pfizer, which makes the orignal...
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Impax Laboratories today announced that late Friday, June 3, it received a warning letter from the Food and Drug Administration dated May 31, 2011 related to an on-site inspection of its Hayward, California manufacturing facility conducted between December 13, 2010 and January 21, 2011...
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Dr Reddy's Laboratories today said it has launched three generic products in the US market.
The company has launched Donepezil Hydrochloride tablets, Venlafaxine Hydrochloride extended release capsules and Letrozole tablets USP, in the US market, Dr Reddy's Laboratories said in a filing to the Bombay Stock Exchange...
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The US Food and Drug Administration has allowed Actavis to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5mg CIV...
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Mylan Inc today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Donepezil Hydrochloride Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept Tablets, which are used to treat dementia associated with Alzheimer's disease...
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Days after a study indicated that hormone-blocking pills called aromatase inhibitors can reduce the risk of breast cancer, generic drugmaker APP Pharmaceuticals Inc. said Tuesday it will start marketing a version of the drug...
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Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited, has been granted final abbreviated new drug approval from the United States Food and Drug Administration for Mupirocin ointment USP, 2%...
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Taiwan has ordered pharmaceutical giant GSK to recall an antibiotic used to treat infections in children for containing a chemical additive...
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The conventional thinking on Wall Street has been that Pfizer Inc.'s blockbuster anti-impotence pill Viagra will begin facing competition from cheaper generic knockoffs in the U.S. once its basic patent expires in 2012...
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Merck and Hanwha Chemical Corporation today announced that they have entered into an exclusive global agreement to develop and commercialize a candidate biosimilar form of Enbrel...
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Pronova BioPharma today announces that it and its U.S. marketing partner, GSK have received a Paragraph IV Notice Letter from Endo Pharmaceutical advising that Endo has submitted an Abbreviated New Drug Application to the FDA...
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Watson Pharmaceuticals, a leading integrated global pharmaceutical company, today confirmed that the United States District Court for the District of Nevada denied Duramed Pharmaceuticals, request for a preliminary injunction and request for a temporary restraining order preventing Watson's launch of generic Seasonique...
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New Zealands Douglas Pharmaceuticals will launch Silvasta a generic of Viagra, a treatment for erectile dysfunction, on Monday June 20 ...
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Watson Pharmaceuticals confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Dutasteride Capsules, 0.5 mg...
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Hi-Tech Pharmacal announced today that the US Food and Drug Administration granted final approval for the Company's Abbreviated New Drug Application for levofloxacin oral solution...
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Depomed Inc. today announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries Inc., for infringement of the patents listed in the Orange Book for Depomed's 500 mg and 1000 mg Glumetza...
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Intellipharmaceutics International today announced that Intellipharmaceutics and Wyeth LLC, a wholly owned subsidiary of Pfizer, have settled the patent infringement litigation in the United States District Court for the Southern District of New York, relating to Intellipharmaceutics' generic version of Effexor XR capsules...
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A subsidiary of Sun Pharmaceutical Industries has received approval from US Food and Drugs Administration for its abbreviated new drug application to market a generic version of Sumatriptan Succinate injection...
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Six Indian pharma majors are set to enter the United States generic market for Levaquin, an antibiotic approved for treating bacterial infections...
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Mylan Inc. today announced that the U.S. District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application for Budesonide Capsules, 3 mg, the generic version of AstraZeneca's Entocort EC capsules, a treatment for Crohn's disease...
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Indian drugmakers Lupin and Natco Pharma announced yesterday that they have entered into an alliance to jointly commercialize a generic equivalent of UK drug giant GlaxoSmithKlines cancer drug Tykerb ...
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The MMA generally precludes multiple 30-month stays for those applications to which it applies...
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Somaxon Pharmaceuticals said it is suing Mylan Pharmaceuticals for trying to market a generic version of its Silenor sleep medication....
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A U.S. federal court agreed with Watson Pharmaceuticals interpretation of Endo Pharmaceuticals Holdings Inc.'s patent claim for Endo's painkiller patch Lidoderm...
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Elite Pharmaceuticals today announced that it has entered into a commercial Manufacturing and Supply Agreement with ThePharmaNetwork for Methadone Hydrocholoride 10 mg tablets...
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