Generics Industry News Search
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May 2009 News Archive |
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Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. (Mayne) have filed a second lawsuit against Mylan Pharmaceuticals Inc. and Mylan Inc. (Mylan) in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the '161 Patent) which covers DORYX, a tetracycline-class oral antibiotic. The lawsuit is in response to the submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) by Mylan requesting approval to manufacture and sell a generic version of DORYX 150 mg delayed-release tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott previously announced, in December 2008, the filing of a lawsuit against Mylan in response to Mylan's submission of an ANDA requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg delayed-release tablets. Warner Chilcott markets and sells DORYX delayed-release tablets in 150, 100 and 75 mg strengths in the United States under a license agreement with Mayne. ...
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Ranbaxy Pharmaceuticals Inc. announced today that it is conducting a voluntary recall of all lots of Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, USP 100 mg, currently on the market in the U.S. ...
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Drug-maker Aurobindo Pharma said it has received tentative approval from the US drug regulator for anti-depressant tablets Escitalopram Oxalate. ...
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Roxane Laboratories, Inc. announced today the launch of its generic for Mycophenolate Mofetil 250mg Capsules and 500mg Tablets by the U.S. Food and Drug Administration...
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Jubilant Organosys Ltd, headquartered in India, announced today that its subsidiary in the United States, DRAXIMAGE LLC has received US Food and Drug Administration approval for the Company's Abbreviated New Drug Application for DRAXIMAGE's generic Sestamibi....
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Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Depakote (divalproex ER) 250mg Extended-release Tablets....
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Mycophenolate Mofetil Tablets and Mycophenolate Mofetil Capsules. Mycophenolate Mofetil Tablets are AB rated and bioequivalent to CellCept Tablets...
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Major Indian pharma firm Cipla has notified that it has secured tentative approval from the United States Food and Drug Administration (USFDA) for its tenofovir disoproxil fumarate tablets. ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for Mycophenolate Mofetil Tablets, 500 mg, and Mycophenolate Mofetil Capsules, 250 mg...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application for generic Uroxatral Extended Release tablets...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) for generic Uroxatral Extended Release tablets....
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Even as the substitutability of biogeneric or biosimilar medicines with their original patented counterparts continues to be a matter of debate world over, Indian drug companies, which have introduced biogeneric products or copies of biotechnology drugs in the country, are bullish over the marketing prospects of "biogenerics" after patents expire in developed markets....
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration of its supplemental Abbreviated New Drug Application for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen, marketed by Eisai Pharmaceuticals...
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Pfizer has responded to the post-grant opposition filed by Dr Reddy's Laboratories (DRL) against its anti-smoking drug Champix. The company, on Friday, countered DRL's claims which filed the opposition in May 2008 at the Mumbai patent office
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Lupin Ltd. announced that it has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules, Lupin's generic version of Wyeth's antidepressant Effexor XR capsules. As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product on or after 1st of June, 2011, or earlier in certain limited circumstances, but in no event earlier than January 1, 2011. ...
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Actavis launched Pantoprazole tablets in Germany, Ireland, and the Netherlands as the patent expired on 6 May. This is Actavis Group's first own brand launch of this molecule. ...
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Australian drug developer, Alchemia Limited, today announced that its global manufacturing and U.S. marketing partner Dr Reddy's Laboratories has received notice of acceptance of its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) for Fondaparinux Sodium...
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GlaxoSmithKline, the pharmaceuticals group, said it would transfer a series of medicines and manufacturing assets to Aspen Pharmacare in an innovative deal that gives it 16 per cent of the South African generic drugmaker....
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Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received yet another approval from the Therapeutic Goods Administration (TGA), Government of Australia for the registration of Simvastatin Tablets 5, 10, 20, 40 & 80 mg. ...
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A U.S. appeals court Wednesday upheld a lower court ruling that protected Procter & Gamble Co.'s (PG) patent rights to osteoporosis drug Actonel, which were under attack from generic competitor Teva Pharmaceuticals Industries Ltd....
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Despite numerous decisions to the contrary in the courts, the FTC continues to vigorously prosecute generic and brand drug makers for entering into agreements settling patent infringement litigation in which the generic firm agrees to delay entry. During your testimony before the Committee, you suggested that you might be opposed to any drug patent settlement that included a so-called reverse payment...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit unanimously affirmed a September 2007 ruling, which denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's Pantoprazole Sodium Delayed Release (DR) Tablets...
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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 (ANDA) for Ursodiol Tablets USP, 250 mg and 500 mg. Teva's Ursodiol Tablets are the AB-rated generic equivalents of Axcan's Urso 250 and Urso Forte, which are indicated for treatment of patients with primary biliary cirrhosis. Shipment of this product has commenced....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit unanimously affirmed a September 2007 ruling, which denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's Pantoprazole Sodium Delayed Release (DR) Tablets...
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Teva Pharmaceutical Industries Ltd. and Lonza Group Ltd. today announced that the European Commission granted antitrust approval to the joint venture between the two companies, which was originally announced on January 20, 2009...
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Gilead Sciences Inc. filed a second lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA Inc. and Teva Pharmaceutical Industries Ltd. alleging patent infringement....
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Prominent drug manufacturer Pfizer is one of three companies that says it will be irreparably harmed if two other major drug makers, including Mylan Pharmaceuticals, are allowed to sell a drug used to treat fibromyalgia....
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Strides Arcolab Limited (Strides) today announced receipt of 2 ANDA approvals....
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Infringement of U.S. Patent Nos. 6,372,252 and 6,955,821 following a Paragraph IV certification as part of Watson's filing of an ANDA ...
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India's generic maker Lupin is being sued by Genzyme Corporation of UK for alleged infringement of its patent in the United States District Court of Maryland on kidney disease drug Renvela
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that the Swiss Chambers of Commerce Court of Arbitration has ruled that the Ferrlecit (sodium ferric gluconate complex in sucrose) supply and distribution agreements between Watson and Sanofi-aventis will expire on December 31, 2009. As a result of today's decision, Watson will continue to market and sell Ferrlecit through December 31, 2009. ...
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Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Precose Tablets (acarbose), 25 mg, 50 mg and 100 mg strengths...
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Oscient Pharmaceuticals Inc. said it received notice this week that Paddock Laboratories Inc. has filed an application to make a generic version of its high-cholesteral medication ANTARA capsules....
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Novartis AG agreed to buy Ebewe Pharma's injectable-drug unit for $1.2 billion in cash to gain generic copies of cancer treatments, including chemotherapy. ...
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A U.S. court has granted an injunction that bars Apotex from selling a generic version of AstraZeneca's lucrative Pulmicort Respules asthma medicine prior to a patent infringement trial, the British drugmaker said on Wednesday....
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Synthon Pharmaceuticals, Inc. believes that it is the 'Single First Filer' of an ANDA with a Paragraph IV certification for the Xyzal (Levocetirizine) Oral Solution product...
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Pfizer, the world's largest drug maker, has acquired rights to 55 generic pills and 20 injectables for more than 70 emerging and developed markets through new deals. Pfizer Inc, has entered into a licensing pact with Indian generic injectables producer Claris Lifesciences besides expanding it present alliance with Aurobindo....
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Watson Pharmaceuticals, a leader in generic and specialty branded pharmaceuticals, announced today the launch of Gelnique (oxybutynin chloride) gel 10%, first and only topical gel for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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Taro Pharmaceutical Industries Ltd. reported today that its Canadian manufacturing site has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sulfacetamide Sodium Topical Suspension USP, 10% lotion...
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Teva Pharmaceuticals, the Israel based generic major, has reportedly settled its patent litigation with the Ahmedabad-based Cadila Healthcare and its US-based subsidiary Zydus Pharmaceuticals Inc concerning the process of making carvedilol, the key ingredient in Coreg, a beta blocker used to treat high blood pressure...
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Counterfeit medicines were left off this year's truncated World Health Assembly agenda but still managed to have an impact. The contentious, intellectual property-related issue arose during a discussion on the World Health Organization's future plans, as several nations objected to a budget line referencing a programme to combat counterfeit drugs...
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Daiichi Sankyo Co., Ltd. and Ranbaxy Laboratories Limited today announced that Mr. Malvinder Mohan Singh has stepped down from the positions of Chairman, CEO and Managing Director of Ranbaxy with immediate effect. Mr. Atul Sobti, currently Ranbaxy's Chief Operating Officer, has been appointed as CEO and Managing Director. Dr. Tsutomu Une, Non-executive Director of Ranbaxy, has been elected as Chairman of the Board....
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Teva has filed patent infringement lawsuit against Innovator Company Amgen w.r.t Cinacalcet process patent infringement in Distric court for Eastern district of Pennsylvania. Generic pharma giant Teva got following process patent....
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Glenmark Generics Ltd\'s US subsidiary announced that the US Food and Drug Administration has granted tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC\'s hypercholesterolemia treatment Zetia (ezetimibe)...
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A reexamination of a key patent for Merck & Co.\'s (MRK) blockbuster Singulair allergy and asthma drug has been ordered by the U.S. Patent and Trademark Office since a new question of patentability has been raised by a New York firm...
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Mylan Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Montelukast Sodium Tablets, 10 mg...
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