Generics Industry News Search
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February 2010 News Archive |
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Cephalon Inc. agreed to buy Mepha Gruppe, one of two drugmakers being sold by Germany's Merckle family, to gain generic drugs and double the size of its international business....
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Actavis has sold Norgesplaster, its manufacturing facility for plasters and athletic tape and adhesive coating, in Vennesla, Norway, to a newly formed entity Norgesplaster AS. Norgesplaster AS is a legal entity owned by private Norwegian investors. The transaction covers all assets and contracts related to Norgesplaster. ...
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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 Tablets, 250 mg, 500 mg, 750 mg and 1000 mg ...
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INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application for ibutilide fumarate injection (the generic equivalent of Corvert from Pfizer Inc)...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has accepted for filing Teva's Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor 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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Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications. ...
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The European Union (EU) and India have resumed Free Trade Agreement (FTA) talks, amid claims that the EU is trying force India to accept pharmaceutical patent terms that go beyond world trade agreements.
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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Solution 1mg/mL (OTC) from the US Food & Drug Administration (USFDA). This approval of Cetirizine Hydrochloride Solution is under over-the-counter (OTC) product category. ...
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Mylan Inc. today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg...
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Teva Pharmaceutical Industries Ltd. announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts...
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Today Merz Pharma entered the Irish Healthcare market with Denzapine, the first generic form of clozapine available in Ireland. Denzapine is an atypical antipsychotic agent used in treatment-resistant schizophrenia (TRS) which has been available to prescribe in the UK since February 2004...
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Infringement of U.S. Patent Nos. 7,297,346, RE37,516 and 7,132,570 following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil...
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Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009...
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Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules...
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The German drug major Bayer AG is planning to move India's Supreme Court seeking protection for its Nexavar (sorafenib) even as Cipla prepares for the launch of a generic version of the kidney cancer drug in a couple of months time following the Delhi High Court's latest verdict upholding an earlier judgment in the case...
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United Laboratories Inc. (Unilab) can still sell its generic version of Pfizer Inc.'s Lipitor in drugstores and retail outlets after a Makati court denied the latter's petition for a preliminary injunction...
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Multinational drug companies have pushed big-time into India in recent years after the country agreed to respect intellectual property rights for pharmaceutical products...
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Perrigo Company today announced that a federal court has granted a summary judgement in its favor in patent litigation involving Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex tablets. Perrigo had been sued by Adams Respiratory Therapeutics, Inc., (a subsidiary of Reckitt Benckiser Group plc.) the New Drug Application holder and patent owner...
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Hospira announced that the standard review period required by the Hart-Scott-Rodino Act for its bid to acquire Chennai, India-based Orchid Chemicals & Pharmaceuticals had expired with no action by the Federal Trade Commission...
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On February 12, 2010, the Food and Drug Administration (FDA) granted tentative approval for efavirenz cross-scored tablets, 200 mg, manufactured by Strides Arcolab Limited of Bangalore, India...
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Two recent cases illustrate how owners of pharmaceutical method-of-use patents may find themselves walking a tightrope when their patents are attacked simultaneously on enablement and obviousness grounds...
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A takeover contract for Ratiopharm, which is being sold to ease the debt burden of its owner, could be drawn up by the end of March, one source said...
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Intellectual property (IP) in trade agreements could endanger the poor man's access to affordable medicines, according to a veteran member of the European Parliament. ...
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Teva Pharmaceutical Industries Ltd. today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva's U.S. generic version of Novartis' Famvir (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007.
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced the addition of milrinone lactate in 5% dextrose injection (0.2mg/mL) in single-dose PVC flexible containers to its existing milrinone injection line. This product is AP rated and is equivalent to Primacor by Sanofi-Aventis...
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., a provider of select specialty injectables, is pleased to announce the addition of Indomethacin for Injection to its existing product line. This product is AP rated and is equivalent to Indocin by Lundbeck Inc...
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In a last ditch attempt to cover for a lawyer who filed a patent extension a day late, smallish biotech The Medicines Co. sued the FDA and the Patent and Trademark Office. It's not as crazy as it sounds. Not quite, anyway...
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GenericsWeb, the leader in pharmaceutical patent analysis and searching, has recently published an article based on its proprietary Pipeline Patent Intelligence to reveal a number of patents that could further delay generic versions of Gatifloxacin beyond this year's expiry of the molecule patent
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Perrigo Co. said Thursday it received marketing approval for a generic version of a medicated shampoo....
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The U.S. Patent and Trademark Office has tentatively rejected certain claims in a key patent for blockbuster anti-clotting drug Plavix, which is co-marketed by Sanofi-Aventis SA and Bristol-Myers Squibb Co....
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Israel-based Teva Pharmaceutical Industries Ltd. won the backing of European drug regulators to sell a generic version of the Eli Lilly & Co. bone-loss drug Evista, Bloomberg reported today.
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An Indian court ruling has halted the international pharmaceutical company Bayer's latest attempt to introduce new measures to weaken competition in drug manufacture in India. By ruling against Bayer on 9 February 2010, the Delhi High Court has refused to undermine measures in India's patent laws that help ensure access to more affordable essential medicines....
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According to Dr. Margaret A. Hamburg, the F.D.A. commissioner, Americans are waiting nearly a year longer for Generics to be approved by the government regulators than they did in 2005. ...
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Some prestigious brand-name pharmaceutical companies that once looked askance at the high-volume, low-cost business of generic drugs are now becoming major purveyors of generic medicines....
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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 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin(TM) ER, which is indicated for major depressive disorder. ...
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In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements. Settlements containing "reverse payments" involved payments from the patent- and NDA-holding, branded drug company to a generic company that has filed an ANDA containing a Paragraph IV certification that an Orange Book-listed patent is invalid or unenforceable...
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A federal court has ruled in favor of Solvay Pharmaceuticals in an antitrust lawsuit brought by the Federal Trade Commission alleging that Solvay conspired with generic drug makers to postpone generic competition for a testosterone-replacement drug...
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President Obama's new proposal for health care reform was unveiled on the White House website earlier this week. According to the White House, the President's plan "builds off of the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as well as by incorporating Republican provisions that strengthen the proposal." ...
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E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx). Fougera's Imiquimod Cream 5% is rated AB, generically equivalent to Aldara by Graceway Pharmaceuticals and substitutable for all indications...
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You'll likely recall that last Spring, Teva said it was going to sell a generic version of Integrilin (Eptifibatide) - and legacy Schering-Plough (now New Merck) responded with a patent infringement suit - that suit covered the '825, '902 and '447 patents, as applied to a 2 mg/mL, 10 mL vial formulation of Integrilin...
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Daiichi Sankyo Co. said Friday it will set up a new subsidiary in April to produce and sell generic drugs in Japan, in a rare move by a domestic maker of branded prescription drugs to tap the growing market of low-priced pharmaceuticals...
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