Generics Industry News Search
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November 2009 News Archive |
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In what has become a classical issue in recent years, the battle between the examination of pharmaceutical patent applications by the Brazilian Patent and Trademark Office (BPTO) and the Health National Surveillance Agency, also known as ANVISA, we may probably have reached its highpoint...
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The U.S. Supreme Court on Monday rejected a generic drug maker's appeal challenging a patent for a blockbuster blood-thinning drug developed by Sanofi-Aventis and co-marketed by Bristol-Myers Squibb Co. ...
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Prasco Laboratories announced today that it has entered into agreements with Winthrop U.S., a business of sanofi-aventis U.S., to provide sales support and distribution services to Winthrop U.S. for authorized generic versions of Allegra-D 12 Hour (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) extended-release tablets and Drisdol (ergocalciferol) capsules in the United States under the Winthrop label. ...
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Teva Pharmaceutical Industries Ltd. announced today the commercial launch of Fexofenadine Hydrochloride 60 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, the same as the sanofi-aventis U.S. allergy treatment Allegra-D 12 Hour (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) Extended-Release Tablets
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Ratiopharm GmbH, the generic-drug maker being sold by Germany's Merckle family to pay off loans, said the "large" number of bids from strategic and financial investors exceeded its expectations
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More generic-drug makers have filed for U.S. approval to market generic versions of Pfizer Inc.'s blockbuster cholesterol pill Lipitor...
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Caraco Pharmaceutical Laboratories, Ltd. has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the US Food and Drug Administration for Sun Pharma's Abbreviated New Drug Application for generic Acular ophthalmic solution on the first day following patent expiration...
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Aurobindo Pharma Ltd. said Friday it has received the final approval from the U.S Food and Drug Administration for selling a generic version of the epilepsy drug, lamotrigine...
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Is this a rare case of Teva Pharmaceutical being forced to swallow its own bitter medicine? The world's largest generic manufacturer, founded on its unflinching willingness to challenge the patented protection of branded products owned by other drugmakers, is suing generic rival Mylan...
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Takeda Pharmaceutical Co., Asia's biggest drugmaker, sued Teva Pharmaceutical Industries Ltd., alleging infringement of a U.S. patent for the insomnia treatment Rozerem...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for an Abbreviated New Drug Application of its subsidiary for generic Acular, Ketorolac Tromethamine Ophthalmic Solution, 0.5%...
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Dr Reddy's Laboratories has filed for marketing a generic version of Pfizer's cholesterol-lowering drug Lipitor in the U.S., the company said on Saturday...
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Aurobindo Pharma announced that it has received final approvals from the US Food & Drug Administration (USFDA) for 2 ANDAs namely Cefotaxime for Injection USP 500mg, 1g, 2g and Cefotaxime for Injection USP 10g pharmacy bulk pack.
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Daiichi Sankyo, which has a majority stake in Ranbaxy laboratories, today said it is going to launch some of Ranbaxy's generic medicine in the Japanese market soon.
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Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg...
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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 (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid (lansoprazole0 Delayed-Release Capsules, 15 mg and 30 mg....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid (Lansoprazole) SoluTab...
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Teva Pharmaceutical Industries Ltd. announced today it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of Copaxone (glatiramer acetate injection)...
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Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the U.S. Food and Drug Administration...
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Depomed, Inc. today announced that it has received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application with the FDA for a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths...
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Aurobindo Pharma Limited is pleased to announce that it's tentatively approved ANDA for Perindopril Erbumine Tablets 2mg, 4mg and 8mg (ANDA No. 079070) has received the final approval from the US Food & Drug Administration (USFDA).
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Mylan Inc. today announced that its subsidiary Mylan SA has received the prestigious 2009 Elsevier Galien Award for Best Generics Company in Spain. The award recognizes the company's outstanding development in the country during the last year and its introduction of new, high quality generic medicines that generate savings for the national health care system. In addition, Mylan Inc.'s efforts in fighting HIV/AIDS in the developing world and the development of a generic biologics strategy contributed to the decision to grant Mylan SA this honor....
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Ratiopharm is up for sale, and it sounds like there are lots of interested buyers. The German company is a big, family-owned generic drug maker, and the generics business is popular these days - lots of blockbusters are going off patent in the next few years, and cost pressures in health care are creating a growing push to have patients take generic drugs when that's an option. ...
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Glenmark Generics Limited has received ANDA approval from the United States Food and Drug Administration for Ciclopirox Olamine Cream, 0.77 % and will commence marketing and distribution of this product in the U.S. Market....
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Glenmark Pharmaceuticals Limited has announced it has entered into an exclusive agreement with Medicis Pharmaceutical Corporation to co-develop and commercialize a specialty pharmaceutical product in North America for the treatment of acne vulgaris. The agreement focuses on a topical pharmaceutical product to be developed from Glenmark's pipeline. In a statement from Glenn Saldanha, Managing Director and CEO, Glenmark Pharmaceuticals Limited mentioned "Both Glenmark and Medicis have extensive experience in the dermatological market segment and this collaboration will allow us to bring a promising new treatment alternative to patients." ...
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Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho-McNeil sells extended-release tramadol tablets under the brand name Ultram ER...
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Sun Pharma announced that the USFDA has granted tentative approval to an Abbreviated New Drug Application (ANDA) for generic Gleevec, imatinib mesylate tablets....
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Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Limited, announced today the settlement of all litigation pending between Glenmark and Medicis Pharmaceutical Corporation relating to the patent actions regarding Fluocinonide, the generic version of Medicis' Vanos cream and Ciclopirox Olamine, the generic version of Medicis' Loprox gel....
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Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration for marketing the 25mg/10 ml injection of Nicardipine HCl, which is used for short-term management of hypertension or increased blood pressure. Nicardipine is the generic name for the brand Cardene, marketed in the United States by EKR Therapeutics....
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Sun Pharmaceutical Industries Ltd. announced that the USFDA has granted its subsidiary an approval for its application for Nicardipine Hydrochloride Injections...
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Pfizer Inc. plans to release generic drugs in Japan as early as 2011, expecting demand to increase as industrialized nations intensify efforts to control drug prices, according to a report Thursday. ...
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Canaccord analyst says, "We think M-Enoxaparin will be approved by Q1/10 and see rapid commercial uptake. M-Enoxaparin is Momenta's generic version of Lovenox, a branded low-molecular weight heparin that is no longer patent protected under the latest court ruling. We believe that Sandoz and Momenta have submitted all necessary safety and efficacy information to the FDA for the review of M-Enoxaparin...
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EU regulators will ask drug companies for details of deals with makers of generic medicines as part of a crackdown on firms suspected of blocking cheaper treatments, a European Commission official said on Thursday...
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On November 18, 2009, after a six day trial, a jury in the United States District Court for the District of New Jersey returned a verdict in favor of Novartis in its infringement suit against Teva Pharmaceuticals...
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New agreements between Pfizer and Aurobindo of India could be coming in the next month or two, Dow Jones Newswires reports this morning, citing execs from both companies who say something's in the works...
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US-based Medicis Pharmaceutical Corporation has filed a case in a US court against Indian drugmaker Lupin, alleging the latter has infringed its patent in applying for marketing approval for a dermatology medicine...
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Oceanside Pharmaceuticals, part of Valeant Pharmaceuticals International, today announced that it has now launched chlordiazepoxide hydrochloride and clidinium bromide, an authorized generic (AG) version of Librax...
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The country's Minister of Trade, Eduardo Saman, declared that the Government invalidated two registered pharmaceutical patents for the antibiotic moxiflocaxin produced by multinational Bayer...
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Sun Pharma announced that the USFDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) for generic Strattera, atomoxetine hydrochloride capsule...
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Nordic private equity firm EQT has teamed up with the former chairman of generic German drug company Ratiopharm, Claudio Albrecht, to bid for the company, according to the Financial Times. Other private equity groups are thought to be interested in buying the world's fourth largest drug manufacturer...
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Ranbaxy Laboratories Ltd. Friday said it has launched a generic version of GlaxoSmithKline's anti-herpes medicine Valtrex in the U.S., a development expected to significantly boost its financial results....
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