Generics Industry News Search
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February 2009 News Archive |
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel 1% (testosterone gel) CIII is unlawful...
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Apotex Inc. of Canada and Intas Biopharmaceuticals Limited (IBPL) of India have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy). Neupeg, a recombinant pegylated granulocyte colony stimulating factor is already manufactured and marketed in India and other countries by IBPL...
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Par Pharmaceutical Companies, Inc. today announced that it learned after the close of business on Friday, January 30, 2009 that the Federal Trade Commission and the California Attorney General filed a lawsuit against Par in the U.S. District Court for the District of Central California. The FTC lawsuit makes antitrust and other allegations about a patent settlement agreement that was approved by the U.S. District Court for the Northern District of Georgia in 2006...
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BioComp Pharma, Inc. launched Tinidazole 500, the first generic version of the FDA-approved drug Tindamax. Tindamax is the only oral antimicrobial drug approved by the FDA for the treatment of both trichomoniasis and bacterial vaginosis ...
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Actavis Group HF invited bidders to make offers this month for the Icelandic generic-drug company in an auction that could fetch as much as 6 billion euros ($7.8 billion), according to three people familiar with the situation...
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Reddy's Laboratories today announced that it has launched the following five products in the US market during the month of January...
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IMPAX Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for generic versions of Solodyn (minocycline HCI) 45mg, 90mg and 135mg Extended-release Tablets...
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Taro Pharmaceutical Industries Ltd. (Taro, the Company) reported today that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Lamotrigine Tablets (Chewable Dispersible), 5 mg and 25 mg (lamotrigine chewable tablets)...
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U.K. drug developer GlaxoSmithKline PLC is reportedly in talks to buy Indian generic drug developer Piramal Healthcare Ltd. for about $1.5 billion....
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Taro Pharmaceutical Industries Ltd. announced that yesterday, February 5, 2009, it received a warning letter from the U.S. Food and Drug Administration regarding the inspection of the Company's Canadian manufacturing facility in July 2008. This is the first such letter that the Company or any of its affiliates has ever received. ...
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Piramal Healthcare Ltd., a Mumbai-based maker of generic drugs, described speculation that the company is up for sale as "totally unfounded"....
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The German Multinational company, Bayer, had been granted a patent for its drug, Sorafenib tosylate (marketed as Nexavar by the company), in India a few months back. The drug is used for the treatment of renal cell carcinoma (a type of cancer of the kidneys) and for treating advanced cases of hepatocellular carcinoma (a form of liver cancer). It is also being investigated for use in other forms of cancer....
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Shire Plc's kidney drug Fosrenol has been threatened by generic competition in the United States, the British speciality pharmaceuticals group said on Monday...
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Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched Cefazolin for injection, USP, an essential antibiotic used to treat serious infections, in a 500mg single-dose vial.
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OSI Pharmaceuticals, Inc. announced today receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Tarceva (erlotinib). ...
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Pharmaceutical company Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to launch the generic version of GlaxoSmithKline Plc.'s anti-migraine medicine Imitrex
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Teva Parenteral Medicines, Inc. has submitted an Abbreviated New Drug Application to the FDA for approval to market a generic version of Cubicin (daptomycin for injection). Cubist plans to file a patent infringement lawsuit against TPM in response to the ANDA filing
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of GlaxoSmithKline's Imitrex tablets...
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Par Pharmaceutical Companies, Inc. today announced that on February 9, 2009, following a bench trial, the district court entered a judgment in favor of Pentech Pharmaceuticals, Inc. and against Par in the amount of $69,955,476. As a result of the court's decision, Par will accrue additional reserves of approximately $28 million on an after-tax basis in the fourth quarter of 2008. ...
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The generic industry is in trouble again, and the issue is now becoming a major non-tariff barrier against developing countries like India.
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German drugmaker Bayer has taken generics supplier Cipla to court for seeking approval for a copycat version of Bayer's cancer drug Nexavar in India, Bayer said on Wednesday....
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Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levetiracetam Oral Solution, 100 mg/mL ...
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Teva Pharmaceuticals USA launched its first awareness campaign on February 10 to raise understanding about the economic value of generic drugs as the US prepares for the possibility of healthcare reform in 2009.
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Merck signaled its clear intent to get aggressive about the biosimilar business with this morning's announcement that the pharma giant is buying Insmed's portfolio of follow-on biologics for $130 million in cash. Merck's BioInvest will take over the development of INS-19 and INS-20, both intended to mimic existing biologics that prevent infections in cancer patients receiving chemotherapy. INS-19 is in late-stage trials while INS-20 is in early-stage development.
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The company that holds the patent for a drug co-promoted by Inspire Pharmaceuticals has decided not to fight efforts to sell generic copies of the medicine. The move will likely bring an end to one of Inspire's revenue streams - and sooner rather than later....
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The question that arises is whether authorised generics increase price competition and contribute to providing affordable medication or do they discourage generic firms from pursuing Paragraph IV challenges...
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Synthon is pleased to announce that it has successfully completed multiple decentralised procedures for its newest product within its comprehensive portfolio: Montelukast...
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Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union...
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Novartis, the Swiss pharmaceutical group, has removed its generics arm from membership of the drug industry's international trade body - a move rivals fear creates a two-tier system that could lower ethical standards.
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Ranbaxy, Dr Reddy's and other Indian drug makers, which earn a third of their earnings from selling products in the US, need higher drug approvals from the Food and Drug Administration (FDA) of that country in the next financial year to maintain 20 per cent sales growth.
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Drug maker Sepracor Inc. said two competitors have filed applications to produce and market generic versions of its blockbuster sleep aid Lunesta.
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Another big drug company is fighting with a generics maker over how soon a top-selling drug can go generic.
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Teva Pharmaceutical Industries Ltd hopes to seek U.S. approval for its version of Amgen Inc's Neupogen this year, company officials said on Wednesday, as it seeks to establish leadership in the emerging field of generic biotech medicines
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Aurobindo Pharma Limited is pleased to announce that it has received tentative approval for Tenofovir Disoproxil Fumarate Tablets, 300mg from the US Food & Drug Administration (USFDA). ...
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Mylan Inc. today announced that its Chief Financial Officer, Edward J. Borkowski, will transition out of his role over the next several months. Borkowski will remain with Mylan until a successor is named and in place. ...
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Endo Pharmaceuticals and Penwest Pharmaceuticals announced that they settled litigation with Actavis South Atlantic LLC regarding the production and sale of generic formulations of Opana ER or oxymorphone hydrochloride Extended Release Tablets CII.
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Perrigo Company today announced that has begun shipping over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg. ...
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American bio-pharmaceutical major Gilead, that has entered into generic licensing deals with 10 Indian pharma firms to distribute its HIV drug Viread, is all set to roll out its key anti-AIDS drugs at affordable prices in India and 94 other resource-limited countries through its unique licensing model....
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Woodcliff Lake, N.J.-based Par Pharmaceutical and Basel, Switzerland-based Novartis have moved to dismiss a patent suit over Par's marketing of a generic version of Lotrel...
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A federal appeals court on Tuesday upheld a trial judge's decision to delay Teva Pharmaceutical Industries Ltd.'s bid to market a generic version of Eli Lilly & Co.'s blockbuster osteoporosis drug Evista...
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The Coalition for a Competitive Pharmaceutical Market strongly praised today's comments made by House Energy and Commerce Committee Chairman Henry Waxman promoting the Hatch-Waxman model be used for legislation establishing a regulatory, scientific and legal pathway for biogenerics...
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The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers....
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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, received the first and only World Health Organization approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates...
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced FDA approval to begin shipping Sumatriptan Succinate Injection...
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India's largest drugmaker has falsified laboratory tests for generic drugs that had been approved for sale in the United States, officials at the Food and Drug Administration say. ...
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French drug major Sanofi-Aventis has emerged as the front-runner to buy a substantial stake in Piramal Healthcare (formerly Nicholas Piramal) at over 50% premium to the Indian company's current share price, two persons familiar with the development said.
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Pfizer Inc is seeking licensing deals to help turn its burgeoning business focused on generic drugs into a growth engine for the world's largest drug maker over the next several years...
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An unidentified whistleblower has filed a lawsuit against Amgen Inc. (AMGN) accusing the biotechnology company of illegal marketing of its blockbuster drugs Enbrel and Aranesp....
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