Generics Industry News Search
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December 2009 News Archive |
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Teva Pharmaceutical Industries Ltd., today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer...
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Cipla Ltd is in talks with a host of global drug makers, including Pfizer Inc, to supply generic products, a top official of the Indian drug maker said, sending its shares up more than 3 percent...
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GSK announced that yesterday it completed the extension of its strategic relationship with Aspen Pharmacare Holdings Limited (Aspen) and the acquisition of a minority shareholding in the South African based pharmaceuticals company. ...
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Shire plc, the global specialty biopharmaceutical company, announces that it has settled the litigation with Teva Pharmaceuticals USA, Inc. (Teva) over Shire's supply to Teva of an authorized generic version of Adderall XR. Shire has been supplying Teva with authorized generic Adderall XR since April 1, 2009...
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Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570, 7,297,346 and RE37,516 for the Cephalon product Nuvigil (armodafinil) Tablets ...
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Watson Pharmaceuticals, Inc. today announced that the Federal Trade Commission (FTC) has accepted a proposed consent order for public comment relating to Watson's pending acquisition of privately held Arrow Group and has granted early termination of the Hart Scott Rodino waiting period, thereby permitting the parties to close the transaction...
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Watson Pharmaceuticals, Inc. today announced that it has completed the acquisition of Arrow Group for a combination of cash and stock. The purchase creates a financially strong, global specialty pharmaceutical company with over $3 billion in annual revenues and operations in more than 20 countries...
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Impax Laboratories, Inc. today announced it acquired Abbreviated New Drug Applications from Watson Pharmaceuticals and Cobalt Laboratories, a subsidiary of Arrow Group...
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Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid Oral Solution ...
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Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc. Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited. Watson's 8mg ramelteon tablet product is a generic version of Takeda's Rozerem...
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Pfizer Inc, the world's biggest pharmaceutical company, will start selling generic drugs after 2010 in Japan, Pfizer's Japanese unit said. ...
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Dr. Reddy's Laboratories Inc., a generic drug manufacturer based in India, said Monday that it will spend $16.5 million to expand its Shreveport production plant and create 73 new jobs....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine Hydrochloride (HCl) Extended Release (ER) Capsules, 37.5 mg, 75 mg and 150 mg, the generic version of Wyeth's Effexor XR Capsules, a treatment for major depressive disorder....
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US drug company Gilead Sciences has filed an appeal in the Indian Intellectual Property Appellate Board to challenge a recent order by an Indian Patent Office that rejected two patent claims for its best seller drug Viread (tenofovir disoproxil fumarate). In August, the Indian Patent Office in Delhi shot down two patents sought by the US firm for Viread after patient groups and Indian company Cipla challenged its patentability...
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Ranbaxy Laboratories Limited (Ranbaxy) and Nippon Chemiphar (NC) today announced the dissolution of their joint venture "Nihon Pharmaceutical Industry Co. Ltd" (NPI), in Japan. This follows an agreement between the two companies that allows NC to purchase the entire shareholding of its erstwhile partner. Both companies held equal shares in the JV. Following the transaction, NPI will become a wholly owned subsidiary of Nippon Chemiphar....
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Pfizer Inc., which became the biggest drugmaker selling widely prescribed pills such as the Lipitor heart medicine, is preparing to enter the business of making cheaper copies of pricey, injectable drugs from biotechnology ...
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Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, Denmark's H. Lundbeck A/S and other pharmaceutical companies were raided Wednesday by the European Union as part of an antitrust investigation. ...
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Perrigo Company today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex Spray...
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Ranbaxy Laboratories Ltd. will launch its generic version of the urinary disorders drug, Flomax, in the U.S. in March 2010, a top executive said Thursday, allowing the Indian drug maker take advantage of its "first-to-file" status...
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Lannett Company, Inc. today announced that it has received approvals from the U.S. Food and Drug Administration of its Abbreviated New Drug Applications for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg, the generic equivalent of Purdue Pharmaceuticals' Dilaudid Tablets 2 mg, 4 mg and 8 mg...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg...
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French multinational drug major sanofi-aventis has joined the list of drug majors eyeing the generic or copycat drug sales opportunity in the Indian market...
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Cubist Pharmaceuticals, Inc. today announced that a trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016...
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In a filing with the U.S. Securities and Exchange Commission (SEC), Cephalon, Inc. announced that it has filed a lawsuit in the US District Court in Delaware against Actavis Group, Actavis Pharma Manufacturing Pvt. Ltd. and Actavis Inc. Actavis is seeking to launch a generic version of Cephalon's sleep franchise product, Nuvigil...
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Strides Arcolab Limited (Strides) announced receipt of Court Orders for the Transferor Companies from the Hon'ble High Court of Karnataka at Bangalore and the Hon'ble High Court of Judicature at Madras sanctioning the Composite Scheme of Arrangement. ...
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This is the case where Ranbaxy was FTF on a pre-MMA basis, but certified P-III as to the '841 patent, which expires in Nov. 2010 and P-IV'd the rest. Teva filed the same certifications in its original ANDA, but later amended with a P-IV to the '841 patent but had a preliminary injunction granted against it on 3.28.08...
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AstraZeneca has failed to win a summary judgment in a patent battle over its blockbuster cholesterol drug Crestor, denying it early victory in one key aspect of a dispute that will go to full trial in February 2010...
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, and Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company and among the top-five generic beta-lactam antibiotics manufacturers globally, today announced an agreement for Hospira to acquire Orchid's generic injectable finished-dosage form pharmaceuticals business for approximately $400 million. ...
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India's Dr. Reddy's Laboratories Ltd. said Tuesday it has launched a generic version of over-the-counter omeprazole--a copycat of AstraZeneca PLC's (AZN) Prilosec for treating stomach ulcers and heartburn--in the U.S. ...
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Biogenerics is a field that is becoming more and more important to Teva Pharmaceutical Industries Ltd. and the company seeks to deepen its existing ties in this area with Swiss company Lonza. Sources inform "Globes" that Teva president and CEO Shlomo Yanay, CFO Eyal Desheh, and all the company's board, flew to Switzerland for two days of meetings intended to extend the collaboration between the two companies...
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Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received approval from Therapeutic Goods Administration, Government of Australia for the registration of Citalopram Hydrobromide Tablets 10mg, 20mg & 40mg
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URL Pharma, Inc. today announced that its subsidiary, Mutual Pharmaceutical Company, Inc., received approval from the U.S. Food and Drug Administration (FDA) for Donepezil hydrochloride orally disintegrating tablets (ODT) 5mg and 10mg. This product is bioequivalent and AB-Rated to Aricept ODT, which is indicated to treat dementia related to Alzheimer's disease. ...
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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Syrup 1mg/mL from the US Food & Drug Administration ...
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A recent decision from the U.S. District Court for the Northern District of Illinois (Eastern Division) presents an interesting solution to a concern about the forfeiture of 180-day exclusivity when a company submits an ANDA containing both a Paragraph IV Certification to one patent and a Paragraph III Certification to another Orange Book-listed patent that does not expire until well into the future...
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India's leading generic company Dr Reddy's has another setback on schizophrenia drug Zyprexa generic as the UK Court of Appeal upheld the validity of Eli Lilly's patent. Zyprexa contains olanzapine an antispychotic drug to treat schizophrenia symptoms...
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The U.S. Patent and Trademark Office has made sure that Merck's Singulair team enjoys its weekend. The PTO reversed its tentative rejection of key claims in the company's patent for the blockbuster allergy and asthma treatment. And the patent regulator says it's done with re-examining Singulair's patent coverage.
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Teva UK Limited has launched generic co-beneldopa capsules in a variety of strengths. The company says that they are the first generic to reach the market...
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Hyderabad-based drug maker Dr Reddy's Laboratories plans to launch generic version of the world's largest selling anti-cholesterol medicine 'Lipitor' in the US market in the next 2-3 years....
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Merck & Co's Schering-Plough unit sued Canadian generic drugmaker Apotex Inc. in an effort to stop a copy of the Nasonex allergy inhaler from being marketed. ...
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS. ...
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Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin(R) Tablets, a cholesterol treatment. ...
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Indian drug maker Lupin Ltd. Tuesday said it has reached an out-of-court settlement with Forest Laboratories Inc. (FRX) and can launch its generic version of the U.S.-based company's Namenda tablets by January 2015, or earlier in certain circumstances....
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Sanofi-Aventis SA dropped its bid for German generic-drug maker Ratiopharm GmbH in favor of deals that add new products and gain the French company entry to new markets, according to two people familiar with the matter....
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URL Pharma today announced the launch of the Colcrys (colchicine, USP) Co-Pay Assistance Program, an initiative designed to save patients money on their health insurance co-payment for Colcrys. The co-pay assistance program allows many patients to pay no more than $25 for a Colcrys prescription, which equates to savings of up to $65 per prescription. Colcrys is indicated for the prevention and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF)....
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Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval or Pramipexole Dihydrochloride tablets, the generic version of Boehringer Ingelheim's Mirapex tablets. ...
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Teva Pharmaceutical Industries Ltd. announced today that Teva-KOWA Pharma Co., Ltd., the Company's joint venture in Japan with KOWA Company, Ltd., has signed a definitive agreement to acquire a majority of the outstanding shares of Taisho Pharmaceutical Industries, Ltd. Under the terms of the agreement, Teva-KOWA Pharma will purchase at least 66.7% of Taisho's outstanding shares. The transaction is expected to close by the end of 2009. Financial terms were not disclosed.
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Novartis CEO Daniel Vasella on Tuesday at the company's annual general meeting said that the stimulant maker plans to continue a lawsuit challenging a section of India's Patents Hoax that aims to restrict unquestionable kinds of patents, despite criticism from some HIV/AIDS advocacy groups and shareholders, Reuters reports (Cage, Reuters, 3/6)....
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The Hyderabad-based Dr Reddy's Labs is planning to launch new generic drugs in various therapeutic segments to give a push to its domestic operations and get back to among the top ten firms in the country.
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