Generics Industry News Search
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May 2012 News Archive |
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Mylan said it began selling a generic version of the antibiotic Doryx today after a judge ruled it didn't infringe a patent held by Warner Chilcott...
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Mylan today announced that it has entered into a settlement agreement with Teva that will resolve pending patent litigation related to Nuvigil...
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Pfizer and Protalix BioTherapeutics announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease...
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Pfizer has settled a lawsuit filed by Brigham Young University (BYU) over development of the blockbuster painkiller Celebrex for $450 million, according to a regulatory filing Tuesday...
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The Sandoz unit of Swiss drugmaker Novartis AG infringes a U.S. patent licensed by Hospira for the sedative Precedex...
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Acella Pharmaceuticals, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) for Gabapentin...
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Novartis has signed a definitive agreement to acquire specialty dermatology generics company Fougera Pharmaceuticals...
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Breckenridge Pharmaceutical announced today that it has finalised its agreement with Zhejiang Huahai Pharmaceuticals (Huahai) to market Nevirapine tablets...
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Actavis has launched Candesartan and Candesartan HCT on many of Europe's biggest pharmaceutical markets, immediately after the patents expired...
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Otsuka's pharmaceutical unit and partner Bristol-Myers Squibb won an appeals court ruling that will help ward off generic-drug competition to their schizophrenia drug Abilify until April 2015...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Mesalamine delayed-release tablets...
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Cell Therapeutics (CTI) today announced that it has received conditional marketing authorization from the European Commission (EC) for Pixuvri (Pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL)...
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Actavis today announced the launch of Atorvastatin, the generic equivalent of Pfizer's Lipitor/Zarator the world's top selling drug...
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Gilead today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Disoproxil Fumarate, for the treatment of HIV-1 infection in treatment-naive adults...
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Eisai announced today that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with 1 abstention, at a meeting held on May 10, 2012 (local U.S. time) that the available data adequately demonstrate that the potential benefits of the anti-obesity agent Lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals...
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Mylan today announced that it has launched Atorvastatin calcium tablets, 10 mg, 20 mg, 40 mg and 80 mg in France, Belgium, the UK, the Netherlands and Ireland...
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Novartis sued Lupin and Torrent Pharmaceuticals for infringing patents on its Exforge HCT blood-pressure medicine...
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For more than a decade, cardiologists treating patients who have had a heart attack have routinely scribbled one drug onto their prescription pads: Clopidogrel bisulfate, better known as Plavix...
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Lupin and Aurobindo Pharma today said they have received US health regulator's approval to sell generic Combivir tablets, used in treating HIV infection, in the American market...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel tablets, 75 mg and 300 mg...
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Sagent Pharmaceuticals today announced the launch of Irinotecan injection, the generic form of the chemotherapy drug Camptosar...
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Dr. Reddy's announced today that it has launched Clopidogrel tablets, 75 mg & 300 mg, a bioequivalent generic version of Plavix in the US market on May 18, 2012...
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Digestive Care (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets,1 mg/0.01 mg and 0.01 mg and 75 mg...
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Sagent Pharmaceuticals today announced the launch of Atracurium besylate injection, the generic form of the neuromuscular blocker Tracrium...
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Perrigo today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg)...
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Actavis, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip XL...
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Cumberland Pharmaceuticals, the maker of prescription drugs for emergency medicine, accused generic drug makers Perrigo and InnoPharma of infringing its patent...
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Noven Pharmaceuticals 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 its Lidocaine topical patch 5%...
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Dr. Reddy's Laboratories announced today that it has launched over-the-counter (OTC) Lansoprazole delayed-release capsules in the US market following Dr. Reddy's ANDA approval by the United States Food & Drug Administration (USFDA)...
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Prodigy Generics, a division of Prodigy Health Supplier Corporation, has launched injectable Irinotecan...
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Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Butoconazole nitrate 2% vaginal cream...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nevirapine tablets...
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Benztropine mesylate, Levetiracetam and Tranexamic acid injectables are newest additions to critical care portfolio...
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Everett, Women's Health Care company, leader in the field of prenatal supplementation, today announced that it had filed a patent infringement lawsuit with a motion for a preliminary injunction in the United States District Court of New Jersey against Trigen, a specialty niche pharmaceutical company...
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Auxilium and FCB announced today that they filed a lawsuit against Watson for infringement of FCB's ten patents listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") as covering Testim 1% testosterone gel...
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Mylan today announced that Mylan Specialty, f/k/a Dey Pharma, has entered into an agreement with Sunovion Pharmaceuticals, f/k/a Sepracor, to resolve the parties' patent litigation relating to Sunovion's Brovana product...
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Mylan today announced that its UK and Italy-based subsidiaries have launched Ibandronic acid film coated tablets...
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Sun Pharmaceutical Industries announced that the USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) for its generic version of Astelin, Azelastine HCL nasal spray...
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A unit of Japan's Astellas sued Hospira (HSP), accusing the generic pharmaceutical company of infringing a patent for the drug Adenosine, used to diagnose heart blockages...
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Mylan today announced that its subsidiary Mylan Laboratories (formerly Matrix Laboratories) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin calcium tablets...
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Watson Pharmaceuticals today announced that its subsidiary, Watson Laboratories, has entered into an agreement with Endo Pharmaceuticals and Teikoku Seiyaku to settle all outstanding patent litigation related to Watson's generic version of Lidoderm...
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IntelGenx today announced the completion of the pivotal bioequivalence study for a novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT orally disintegrating tablets...
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Perrigo today announced that the U.S. Food and Drug Administration has granted final approval to Tris Pharma for its Abbreviated New Drug Application (ANDA) for Dextromethorphan polistirex extended-release oral suspension...
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Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Nifedipine extended-release tablets, USP, 90 mg, a generic equivalent to Bayer's Adalat...
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