Generics Industry News Search
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January 2006 News Archive |
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Teva Pharmaceutical Industries Ltd. announced today that the U. S. Food and Drug Administration has granted tentative approval for the Company’s ANDA for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg....
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Glenmark Pharmaceuticals SA, a wholly owned Swiss Subsidiary of Glenmark Pharmaceuticals Ltd. has acquired Bouwer Bartlett Pty. Ltd., a South African sales and marketing company, for an undisclosed consideration....
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Sun Pharma today announced it has successfully completed the purchase of dosage form manufacturing operations of Able Labs in the US for USD 23.15 million by its wholly owned subsidiary company, Sun Pharmaceutical Inc, Michigan. The US Bankruptcy Court of the District of New Jersey, Trenton, had accepted the Sun Pharma bid as the highest, earlier this year....
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Swiss pharmaceutical company Roche has granted Hetero Drugs a sub-license for the production and marketing of Oseltamivir (generic “Tamiflu”). Under the sub-licensing agreement, agreed on 21st December, 2005, Roche authorizes Hetero to manufacture and market both the active pharmaceutical ingredient (API) and finished product of Oseltamivir, for supply to India, least developed countries and developing countries....
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Par Pharmaceutical Companies, Inc. today announced that it has entered into agreements with Teva Pharmaceutical Industries Ltd., Ivax Corporation and an affiliate of Teva to purchase for cash eight products that are currently marketed in the U.S. by Ivax or Teva....
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J. B. Chemicals & Pharmaceuticals Ltd., a leading pharmaceutical player with a dominant presence in Russia and CIS countries today announced its plans to set-up a Wholly Owned Subsidiary in Moscow, Russia, called “OOO Unique Pharmaceuticals Laboratories.”...
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Allergan, Inc. announced today that on December 29, 2005, in its patent infringement lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma, the United District Court for the Northern District of California granted Allergan's and Syntex (USA) LLC's application for a temporary restraining order against the Defendants. In its ruling, the District Court ordered that the Defendants are restrained and enjoined, pending the Court's decision as to whether a preliminary injunction should issue, from commercially manufacturing, using, offering to sell, or selling within the United States or importing into the United States the generic version of ACULAR(R) (ketorolac tromethamine ophthalmic solution) 0.5% for which the Defendants have sought FDA approval via an abbreviated new drug application....
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Bradley Pharmaceuticals, today announced that the Company has established A. Aarons Inc., a subsidiary of Bradley Pharmaceuticals, to market, on a select basis, authorized generic versions of therapies provided by Bradley's Doak Dermatologics and Kenwood Therapeutics operating units....
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IntelliPharmaCeutics Corp. of Toronto, Ontario is pleased to announce that it has entered into an agreement with ratiopharm inc. of Mississauga, Ontario, for the development of a generic, controlled release drug product for the Canadian market....
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Ranbaxy Laboratories Limited announced today that the Company has entered into a co-marketing agreement with Ferring International of Switzerland, a speciality biopharmaceutical company, for its product Desmopressin, a structural analogue of the pituitary hormone Arginine Vasopressin....
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Cephalon, Inc. announced today that it has entered into an agreement with Mylan Pharmaceuticals Inc. to settle its pending patent infringement dispute in the United States related to PROVIGIL(R) (modafinil) Tablets [C-IV]....
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The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Desoximetasone Gel USP, 0.05%....
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Mylan Laboratories Inc. and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. announced today that the two companies have entered into an agreement for the commercialization, development and distribution of Mylan's novel beta blocker nebivolol in the United States and Canada....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s ANDA for Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg....
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Sepracor Inc. today announced that it has been notified that the U.S. Food and Drug Administration (FDA) has received an abbreviated new drug application (ANDA) from Dey, L.P. for a generic version of levalbuterol hydrochloride inhalation solution....
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Elite Pharmaceuticals, Inc. has entered into a development and commercialization agreement with Orit Laboratories, LLC....
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Wyeth announced today that the settlement of the litigation between Wyeth and Teva concerning Teva's application to market a generic version of Wyeth's Effexor(R) XR extended release venlafaxine capsules became effective today upon the entry of certain orders by the United States District Court for the District of New Jersey and the execution of certain settlement documents by the parties....
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced the signing of an exclusive, multi-product contract manufacturing agreement with Wintac Limited, an Indian pharmaceutical company, based in Bangalore....
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Andrx Corporation announced today that the U.S. District Court for the Eastern District of Missouri granted motions for summary judgment filed by Andrx and two other pharmaceutical companies with respect to each company's abbreviated new drug applications (ANDA) for the generic version of Toprol-XL(R) (metoprolol succinate extended-release tablets)....
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Pfizer Inc said today that a federal court in the Northern District of Illinois (Chicago) has upheld the company's U.S. patent covering amlodipine besylate, the active ingredient in Norvasc, the world's most-prescribed branded medicine for treating hypertension....
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Further details can be found on the Patent Baristas website by clicking the link below....
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Actavis Group, the international generic pharmaceuticals company, announces that it has launched two medicines, Lanzoprazole and Glimepiride, into the Danish and Finish markets....
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Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Rabeprazole Sodium Delayed-release Tablets, 20 mg....
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IMPAX Laboratories, Inc. today announced that it has reached a settlement with an affiliate of Britain's Shire Pharmaceuticals Group Plc covering all patent litigation, (involving Shire's U.S. patents Nos. 6,322,819 and 6,605,300), between the parties related to Adderall XR(R) (mixed amphetamine salts)....
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Andrx Corporation announced today that it has entered into an agreement with InvaGen Pharmaceuticals Inc. to commercialize 11 abbreviated new drug applications, which, according to IMS data, had total brand sales exceeding $13 billion for the trailing 12 months ended September 2005....
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Actavis Group, the international generic pharmaceuticals company, today announces that it has acquired the remaining 11% stake in the Turkish generic pharmaceuticals company Fako for US$20.4 million....
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Teva Pharmaceutical Industries Ltd. and IVAX Corporation announced today that the U.S. Federal Trade Commission has accepted the proposed consent order for public comment and granted early termination of the Hart Scott Rodino waiting period, thereby permitting the parties to close the transaction....
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On December 28, 2006, the Federal Circuit Court of Appeals denied Savient Pharmaceuticals' motion for a preliminary injunction, pending appeal, to prevent Sandoz and Upsher-Smith from marketing their generic Oxandrin (Oxandrolone) products....
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Apotex Corp. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel bisulfate 75 mg tablets....
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Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals U.S.A., Inc., its U.S. affiliate, has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Betamethasone Dipropionate Lotion (Augmented) USP, 0.05% (augmented betamethasone dipropionate lotion)....
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Par Pharmaceutical Companies, Inc. today announced the divestiture of FineTech Laboratories Ltd., effective December 31, 2005. Acquired by Par in 2002, FineTech employs 42 people at its research and development facility in Haifa, Israel....
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Barr Pharmaceuticals, Inc. today confirmed that the Unites States District Court for the District of New Jersey has denied a motion filed by Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. that would have forced Barr and Teva Pharmaceutical Industries Ltd. to cease marketing Fexofenadine Hydrochloride 30 mg, 60 mg and 180 mg Tablets, the generic versions of Aventis' Allegra(R) Tablets....
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“The positive CHMP opinion for Omnitrope is an important step on the way to make this medicine available for patients who need it,” said Dr. Andreas Rummelt, CEO Sandoz. “Omnitrope will contribute to cost savings in the Health Care systems and we are confident that the European Commission will now grant marketing authorization.”...
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Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Alprazolam Extended-release Tablets, 0.5 mg, 1 mg, 2 mg and 3 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 ANDA for Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for testosterone gel 1% CIII....
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Caraco Pharmaceutical Laboratories, Ltd., announced today that the U.S. Food and Drug Administration (FDA) have granted tentative approval for the Company's ANDA for the remaining strengths of Carvedilol tablets. Final approval of this product is anticipated subsequent to the expiry of patent protection in March 2007....
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