Generics Industry News Search
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November 2011 News Archive |
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Perrigo Company today announced that its partner, PharmaForce/Luitpold Pharmaceuticals, received final approval for Epinastine HCl ophthalmic solution, 0.05%, a generic version of Elestat. Perrigo will commence shipment of the product immediately...
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The Food and Drug Administration approved Qualitest Pharmaceuticals' application to market Felodipine extended-release tablets...
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Perrigo company announced that it has filed with the U.S. Food and Drug Administration a New Drug Application for Testosterone Gel 1.0% and that it has notified Abbott Products Inc., the owner of the Reference Listed Drug of its filing. On October 31, 2011, Abbott filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act...
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Israeli giant's collaboration with Indian pharmaceutical company Ranbaxy will allow Teva to market world's best selling drug exclusively until 2012. Projected earnings: $1.5B...
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Perrigo company and its partner Synthon pharmaceuticals today announced that Perrigo has begun shipping Levocetirizine solution, 2.5 mg/5ml, a generic version of UCB's Xyzal oral solution. Synthon has the first to file ANDA application for the generic that entitle it to 180 days of generic exclusivity. Hatch Waxman litigation in this product was settled earlier this year. Perrigo is the manufacturer of this product...
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Mylan today announced that it has entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialise Pfizer's generic equivalent to GlaxoSmithKline's Advair Diskus and Seretide Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform...
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Teva Pharmaceutical Industries Ltd. lost a U.S. appeals court bid to stop Watson Pharmaceuticals...
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Watson today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for morphine sulfate extended-release capsules USP, the generic equivalent of Actavis' Kadian...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market rivastigmine transdermal system patches, 4.6 mg/24 hr and 9.5 mg/24 hr...
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Watson Pharmaceuticals, Inc. today confirmed that the United States Court of Appeals for the Federal Circuit affirmed the district court's June 16, 2011 denial of Duramed Pharmaceuticals, Inc.'s request for a preliminary injunction to prevent Watson from selling generic SEASONIQUE ...
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Pharmaceutical giant Allergan Inc. on Friday sued a subsidiary of Indian drugmaker Lupin Ltd. in Texas federal court alleging infringement of a patent for glaucoma medication Lumigan in an ongoing bid to protect the drug from generic competition...
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The Food and Drug Administration has approved a generic drug for treating pain...
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We are pleased to announce the day-one launch of generic Valsartan tablets and capsules, and Valsartan Hydrochlorothiazide (HCTZ) tablets...
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Strides Arcolab has received approval from the US health regulator to market a generic carboplatin injection for the treatment of ovarian cancer...
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Actavis has launched an authorised generic drug for treating pain, the company said...
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Hospira, the world's leading provider of injectable drugs and infusion technologies, today announced the U.S. launch of Imipenem-Cilastatin for injection, I.V., the first generic version of this key antibiotic to become available in the United States...
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Par Pharmaceuticals has completed its acquisition of Anchen Pharmaceuticals...
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Pfizer is seeking to add Express Scripts to the list of U.S. pharmacy benefits managers that won't dispense generic Lipitor after the world's best-selling drug loses patent protection this month...
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US based Warner Chilcott has moved court against Zydus Cadila's plan to produce a bowel inflammation drug Asocol. Chilcott hold exclusive rights over the drug and has filed a patent infringement suit at US's Delaware court to restrain Zydus from introducing the generic version of Asocol...
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Mylan Inc. today announced that it has settled a patent litigation lawsuit with Novartis Pharmaceuticals Corporation related to Vivelle-Dot...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Fentora...
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Actelion today confirmed its intention to appeal the verdict in the case of Asahi Kasei Pharma Corp. v. Actelion Ltd...
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Kremers Urban Pharmaceuticals today announced that it has entered into a settlement agreement which will resolve litigation related to Lipitor tablets...
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Rising Pharmaceuticals, a generic finished dosage form subsidiary of Aceto, has introduced 250 mg and 500 mg strengths of Flucytosine capsules...
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Pfizer and Excaliard Pharmaceuticals, announced today that they have entered into a definitive agreement under which Pfizer will acquire Excaliard, a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring....
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SOHM, a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, today announces the acquisition of business and brands of privately owned Novatrend Medicament....
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Amgen said Tuesday that a new patent had been granted that could protect its big-selling drug Enbrel from generic competition for 17 more years, a development that could undermine some of the savings contemplated in the federal health care legislation...
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Transcept announced today that the U.S. Food and Drug Administration has approved Intermezzo for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep...
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The European Union's highest court backed extended patent protection for drugs and vaccines that are effective against multiple diseases...
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Global drugmaker Pfizer, which had sued Aurobindo Pharma over a patent infringement for one of the best selling drugs Lipitor, has settled the case with the generic drug company...
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Onco Therapies Limited, a wholly owned subsidiary of Strides
Arcolab Limited (Strides) today announced that it has received approvals from USFDA for Carboplatin Injection and Oxaliplatin for Injection...
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Ranbaxy Laboratories Ltd. may have to pay a penalty of up to $400 million to settle issues with the U.S. Food and Drug Administration, which could allow the Indian drug maker to launch its generic version of cholesterol-lowering drug Lipitor in the US...
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The EU Court of Justice yesterday clarified its position on Europe's Supplementary Protection Certificate (SPC) system, which provides additional exclusivity for medicinal products to compensate for the long time needed to gain marketing approval...
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Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection...
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Perrigo Company today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets ...
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Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Montelukast Sodium 10 mg tablets, their generic version of Singulair tablets by Merck...
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The U.S. Patent and Trademark Office has sided with BioDelivery Sciences, dealing a blow to another drug company that claimed patent infringement against BioDelivery...
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Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Myzilra Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) ...
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Watson Pharmaceuticals was granted U.S. Food and Drug Administration approval for its generic version of Bayer AG's Yaz birth-control pill, adding to Watson's stable of products for women's health...
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Watson today confirmed that it has launched an authorised generic version of Lipitor as part of an exclusive agreement with Pfizer. Watson began shipping the product today...
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