Generics Industry News Search
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April 2012 News Archive |
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Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial launch of both Irbesartan and Irbesartan-Hydrochlorothiazide tablets...
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A Polish law allowing the sale of prescription drugs which have not been approved by the European Medicines Agency but are similar to those which have, but are cheaper, contravenes European Union law, the EU Court of Justice has ruled...
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Prasco Laboratories announced it is expanding its supply agreement with Shionogi Inc...
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Shortly after having acquired Cephalon/Mepha's international business in the Middle East, Africa, Asia and Latin America, Acino continues its expansion in global emerging markets under its Acino Switzerland brand by successfully in-licensing the blockbuster drug esomeprazole...
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Watson Pharmaceuticals, today confirmed that its subsidiary, Watson Laboratories, filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market Bimatoprost ophthalmic solution, 0.01% and Bimatoprost ophthalmic solution, 0.03%. Watson's ANDA products are generic versions of Allergan's Lumigan 0.01% and Latisse products, respectively...
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Watson today confirmed that the United States District Court for the District of Delaware has ruled that the asserted claims of United States Patent Nos. 7,410,978 (the '978 Patent), 7,759,359 (the '359 Patent), 7,781,448 (the '448 Patent), 7,781,449 (the '449 Patent) and 7,763,635 (the '635 Patent) for Sanctura XR (Trospium chloride extended-release capsules) are invalid...
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Mylan today announced that its Mylan institutional business has launched Mesna injection, 100 mg/mL, packaged in 1,000 mg/10 mL multiple-dose vials...
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Amylin today announced that it has completed its Biologics License Application submission to the U.S. Food and Drug Administration for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in pediatric and adult patients with rare forms of lipodystrophy...
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GlaxoSmithKline and Pfizer sued Hikma for planning to sell an injectable blood-clot treatment that the drugmakers say infringes a patent licensed by Glaxo for Argatroban...
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Teva Pharmaceutical sued Synthon for infringing seven patents in planning to sell a generic version of the multiple sclerosis drug Copaxone before Teva's patents expire...
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A URL Pharma unit sued Par Pharmaceutical alleging infringement of 10 patents with its plans to market a generic version of the Colcrys gout treatment...
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Mylan has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil...
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ViroPharma said Tuesday that three companies are now selling low-cost generic versions of its drug Vancocin...
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Watson Pharmaceuticals today announced that its subsidiary, Watson Laboratories, has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Vancomycin Hydrochloride Capsules, generic versions of ViroPharma's Vancocin HCl capsules....
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Sanofi's two patents on the cancer drug Taxotere were ruled invalid and unenforceable by a U.S. court yesterday in a victory for generic-drug makers Hospira and Apotex....
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Watson Pharmaceuticals is on track to announce a deal to buy Actavis for around $6 billion by the end of April, creating one of the world's biggest producers of generic drugs, sources familiar with the matter said on Wednesday....
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Prasco Laboratories announced today it will market the Authorised Generic version of Vancocin HCl capsules in 125 mg, and 250 mg strengths in the U.S. under the Prasco label pursuant to its distribution and supply agreement with ViroPharma...
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Impax Laboratories today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise (gabapentin tablets, 300 mg and 600 mg)...
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Perrigo announced that it has initiated shipments of its Guaifenesin Extended-Release Tablets, 600 mg (a generic version of Mucinex 600 mg tablets) product...
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Abbott Laboratories sued the German drug maker Boehringer AG's Roxane Laboratories and accused it of infringing three patents for the HIV drug Norvir...
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The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved generic versions of the atypical antipsychotic medication, Seroquel (quetiapine)...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules...
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Pfizer, the world's largest drugmaker, and its business partners OSI Pharmaceuticals and Genentech sued Roxane Laboratories over its plans to market generic copies of the lung-cancer drug Tarceva...
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ViroPharma sued two federal agencies seeking a court order temporarily blocking approval of generic forms of its biggest product, the antibiotic Vancocin...
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Synthon today announced that its subsidiary Synthon Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for tadalafil tablets...
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Cephalon (TEVA) won an appeals court ruling that could help it block generic versions of the muscle-relaxant Amrix...
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Auxilium Pharmaceuticals and FCB I LLC today announced that they have received a notice from Watson Laboratories...
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The U.S. Supreme Court ruled on Tuesday in favor of a generic drugmaker in a case over how companies can fight brand-name rivals in an effort to get their cheaper medicines to market...
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Inspiration Biopharmaceuticals today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) protein for the treatment and prevention of bleeding in individuals with hemophilia B...
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Pfizer Canada could face some stiff market competition if Canada's top court rules the company's patent on the erectile-dysfunction drug Viagra is invalid...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Metformin Hydrochloride Extended-release Tablets USP, 1000 mg...
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Watson Pharmaceuticals today announced that it has launched an authorized generic version of Fortamet (metformin hydrochloride extended-release tablets) as part of an agreement with Shionogi...
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Par Pharmaceutical Companies today announced that its Par Pharmaceutical operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals to acquire Handa's ANDA for dexlansoprazole capsules, the generic version of Takeda's Dexilant...
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Dr. Reddy's Laboratories announced today that it has launched Olanzapine tablets, a bioequivalent generic version of Zyprexa tablets...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olanzapine Tablets...
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Pharmaceutical and biotechnology major Wockhardt has launched an authorised generic version of four strengths (50 mg, 75 mg, 125 mg and 200 mg) of the triple-drug combination product containing Levodopa, Carbidopa and Entacapone, which are used in treatment of Parkinson's disease...
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Watson Pharmaceuticals and Actavis Group today jointly announced that Watson has entered into a definitive agreement to acquire privately held Actavis for approximately EUR4.25 billion upfront...
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Amgen, the world's largest biotechnology company, and Mustafa Nevzat Pharmaceuticals today announced an agreement under which Amgen will acquire 95.6 percent of shares in MN...
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Opening a new chapter in the history of research & development in India, Ranbaxy today launched India's first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults...
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A Bayer AG unit sued generic drug maker Watson Pharmaceuticals for allegedly infringing two U.S. patents for Staxyn, a medicine approved in the U.S. in 2010 for treatment of male erectile dysfunction...
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Mylan and Pfizer today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Teva that will resolve pending patent litigation related to its Abbreviated New Drug Application (ANDA) for a generic epinephrine auto-injector...
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Hi-Tech Pharmacal announced today the signing of a definitive agreement under which Hi-Tech acquired rights to market generic Lidocaine 5% ointment from Septodont...
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Novartis announced today that the US Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of adult patients with kidney tumours known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery...
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Merck known as MSD outside the United States and Canada, announced today that the U.S. District Court for the District of New Jersey has ruled in Merck's favor in two jointly related patent infringement suits against Mylan Pharmaceuticals...
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Abbott Laboratories has filed a citizen's petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis...
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