Generics Industry News Search
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October 2008 News Archive |
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Indianapolis Eli Lilly & Co. sued generic-drug maker Teva Pharmaceutical Industries Ltd., alleging infringement of two U.S. patents used for the cancer drug Gemzar....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application submitted to the U.S. Food and Drug Administration by a generic filer requesting approval to market and sell a generic version of Oxytrol. ...
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Legislative proposals to exempt certain classes of drugs from generic substitution laws would increase costs by more than $29 billion over ten years if enacted nationally and provide no safety or clinical benefit for patients, according to a study conducted by the healthcare consulting firm Visante for the Pharmaceutical Care Management Association. ...
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OPKO Health, Inc. today announced that it has acquired exclusive worldwide rights from Teva Pharmaceuticals Industries Ltd. (TEVA) to Teva's proprietary formulation of budesonide for the treatment of various inflammatory and allergic conditions of the eye. Teva's proprietary budesonide product is currently marketed in Italy under the tradename XAVIN for the treatment of asthma. ...
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Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd., has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd....
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India has approved Japanese drugmaker Daiichi Sankyo's investment in India's Ranbaxy Laboratories, Finance Minister Palaniappan Chidambaram told reporters after a cabinet meeting on Friday.
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In a typical drug patent case, Impax wanted to barge in on Aventis' patented treatment for Lou Gehrig's disease, so Impax filed an ANDA, then a DJ motion, charging invalidity and unenforceability for inequitable conduct....
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Lannett Company, Inc. today said that the U.S. Food and Drug Administration (FDA) recently completed an inspection of two of the company's manufacturing facilities, including quality systems. The two-year annual cGMP audit concluded with a total of four minor observations. ...
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On October 7, 2008, FDA granted tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets, manufactured by Macleods Pharmaceuticals Limited of Daman, India, indicated for use in combination with other anti-retroviral drugs for the treatment of HIV-1 infection....
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that its wholly owned subsidiary, Cody Laboratories, a manufacturer/supplier of bulk active pharmaceutical ingredients, has received approval from the United States Patent and Trademark Office for its patent regarding a method for the preparation of Hydromorphone and Hydrocodone.
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has approved RAPAFLO (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH....
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Alkermes, Inc. today announced that patients with schizophrenia now have a new administration option for Risperdal Consta The U.S. Food and Drug Administration has approved a new injection site, the deltoid muscle in the arm, for Risperdal Consta for the treatment of patients with schizophrenia. Risperdal Consta was previously approved as a gluteal injection only. ...
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The US Department of Justice today withdrew a motion against Ranbaxy Laboratories after India's biggest drugmaker submitted a comprehensive set of audit documents to the authorities.
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In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt. ...
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Apotex has been awarded damages of GBP17.5 million from Servier in a long-running UK patent dispute over perindopril. Mr Justice Norris of the High Court's Chancery division estimated that the amount would adequately compensate Apotex for profits that it lost during a period when it was prevented by injunction from selling a generic version of Coversyl....
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Heritage Pharmaceuticals Inc. announced the immediate availability of Propranolol HCl Oral Tablets in 10, 20, 40, 60 and 80 mg strength. Heritage's development and manufacturing partner, Ipca Laboratories Ltd., received final approval of its Abbreviated New Drug Application for an AB Rated equivalent of Inderal on June 2, 2008....
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Three of India's leading generic drug makers, Dr Reddy's Laboratories, Ranbaxy Laboratories and Wockhardt, are in race for Germany's largest health insurer Allgemeine Ortskrankenkasse (AOK)'s $3.5-billion drug supply contract.
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Par Pharmaceutical Companies, Inc. today announced a resizing of its generic unit as part of an ongoing strategic assessment of its businesses. This initiative will enable Par to more effectively optimize its current product portfolio and its strong pipeline of first-to-file/first-to-market products. As a result, the Company believes it will be better positioned to compete more profitably and efficiently in the generic marketplace over the long term.
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Par Pharmaceutical Companies, Inc. today announced the resignation of Gerard A. Martino, executive vice president and chief operating officer....
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Tianyin Pharmaceutical, Co., Inc. , today announced that it launched the production of Azithromycin Dispersible Tablets in August 2008 and is due to market the new product in October 2008....
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Bayer's patent on Cipro was challenged by Barr. However, the parties settled on the eve of trial. In all, Bayer paid $398 million to Barr to ensure that it didn't receive a judgment of invalidity or unenforceability....
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Daiichi Sankyo's acquisition of majority shareholding in Ranbaxy Laboratories will be completed in the next one month, Ranbaxy Chief Executive Officer and Managing Director Malvinder Mohan Singh said on Tuesday.
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Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration has granted final approval of the company's abbreviated new drug application for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL.
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ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side....
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Barr Pharmaceuticals, Inc. today announced that the U.S. Court of Appeals for the Federal Circuit has upheld the 2005 decision of the U.S. District Court for the Eastern District of New York, which rejected a challenge to the lawfulness of a 1997 patent litigation settlement. ...
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Japan's Daiichi Sankyo Co said on Friday it had completed the purchase of 20 per cent in India's Ranbaxy Laboratories, part of its plan to obtain a majority holding in the generic drugmaker. ...
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Pozen Inc., today announced that Pozen and GlaxoSmithKline (GSK), the holder of the New Drug Application for Treximet, received a letter from Par Pharmaceutical, Inc. notifying Pozen and GSK that Par submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration for approval to market a generic version of Treximet....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour.
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On Monday, Novartis AG said it hopes that data submitted to the U.S. regulator, as part of a filling for approval of its generic version of Sanofi-Aventis SA's thrombosis drug Lovenox, is now complete. ...
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Australian drug developer, Alchemia Limited, today announced it had received a 'notice of allowance' for the United States patent application titled Synthetic Heparin Pentasaccharides (number 10/488,677)...
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Cephalon, Inc. and Eurand NV today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application submitted to the U.S. Food and Drug Administration by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of Amrix (Cyclobenzaprine Hydrochloride Extended-Release Capsules). ...
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.
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Novartis AG's Sandoz unit lost its bid to begin selling generic versions of the Abbott Laboratories antibiotic Biaxin XL before a trial on a patent dispute over the medicine....
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Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg....
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Mylan Inc. today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol Capsules....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary Watson Laboratories, Inc. has filed a lawsuit in the U.S. District Court of Delaware against Barr Pharmaceuticals, Inc. and its subsidiary Barr Laboratories, Inc. for infringement of patents listed in the Orange Book for Watson's product Oxytrol....
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Auxilium Pharmaceuticals, Inc. and CPEX Pharmaceuticals, Inc. today announced that they have received a notice from Upsher-Smith Laboratories, Inc. advising of the filing by Upsher-Smith Laboratories, Inc. of an Abbreviated New Drug Application containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for testosterone gel. ...
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Sun Pharma is scanning acquisition opportunities in the US, with the global financial meltdown resulting in more attractive valuations of generic drug companies, Sun Pharma's Chairman and Managing Director, Mr Dilip Shanghvi, told analysts.
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Zydus Cadila, an Ahmedabad-based pharmaceutical company, has taken Teva Pharmaceuticals, the world's largest generic drug maker, to court in the US, seeking damages for Teva's antitrust violations and unfair trade practices relating to a drug called risperidone....
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Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. announced today that Barr and its syndicate of lending banks, arranged by Bank of America, have agreed to amend Barr's unsecured credit facilities to permit them to remain in place following Barr's acquisition by Teva.
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Prasco announced today it has begun shipping generic forms of Dorzolamide Hydrochloride-Timolol Maleate and Dorzolamide Hydrochloride Ophthalmic Solutions, comparable to Merck's COSOPT and TRUSOPT....
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Hi-Tech Pharmacal Co., Inc. announced that the U.S. Food and Drug Administration granted final approval to the Company's Abbreviated New Drug Application for dorzolamide and timolol ophthalmic solution...
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The Food and Drug Administration within the U.S. Department of Health and Human Services has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief. ...
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Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has challenged Pfizer Inc.'s patents for its Vfend Tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application. ...
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Hoffman- La Roche has slapped a lawsuit at Indian generic drugmaker Orchid Chemicals & Pharmaceuticals Ltd. over a newly issued patent for Roche's blockbuster osteoporosis drug Boniva. The US Patent, method of treatment using bisphosphonic acid, was issued on August 12, 2008 ...
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Perrigo company today announced that it had received tentative approval from the U.S Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate tablets, 200/38 mg.
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Actavis has entered into an exclusive distribution agreement, for a number of generic products, with J&M; Pharma, Co Ltd, a Korean owned and operated pharmaceutical company, headquartered in Seoul, Korea. The agreement is an important step in building Actavis' presence in the Korean generics market. ...
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Schering-Plough Corporation said today that it strongly believes that the decision reached by a jury in Missouri related to reimbursement by Missouri's Medicaid program of certain products sold by Warrick Pharmaceuticals, the company's former generics subsidiary, was incorrect. ...
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The U.S. Court of Appeals for the Federal Circuit gave a high-five to settlement agreements between a patent holder and a generic manufacturer saying it doesn't violate antitrust laws under the Hatch-Waxman Act....
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