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   September 2005 News Archive news archive  


01/09/2005  Par Licensee gets OK for generic Remeron® news archive
Par Pharmaceutical Cos. said Thursday that its licensing partner Amide Pharmaceutical Inc. received Food and Drug Administration approval to market a generic version of Remeron®, an anti-depressant made by Akzo Nobel unit Organon International Inc....
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01/09/2005  Barr Receives Approval for AllegraR Tablets news archive
Barr Pharmaceuticals, Inc. today announced that Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic versions of Aventis Pharmaceuticals' Allegra(R) (Fexofenadine Hydrochloride) Tablets, 30 mg, 60 mg and 180 mg. ...
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01/09/2005  Alpharma Launches Halobetasol Propionate Ointment news archive
Alpharma Inc., a leading global generic pharmaceutical company, today announced the launch of halobetasol propionate ointment, 0.05%. Alpharma’s halobetasol propionate ointment, which will be available...
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02/09/2005  Ivax distributes US Levothyroxine news archive
Ivax Pharmaceuticals is distributing 11 strengths of levothyroxine sodium tablets in the US under an exclusive licensing agreement to use another company’s recently approved abbreviated new drug application (ANDA)...
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02/09/2005  IMPAX Announces Alza's Lawsuit Related to Generic Version Of Concerta® news archive
IMPAX Laboratories, Inc. today announced that Alza Corporation and McNeil-PPC, Inc. have filed a complaint against the Company in the United States District Court for the District of Delaware, alleging patent infringement related ...
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07/09/2005  Tentative Approval Generic Zidovudine Oral Solution news archive
The Food and Drug Administration (FDA) announced the tentative approval of zidovudine oral solution manufactured by Aurobindo Pharma LTD....
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08/09/2005  Drug maker seeks to block generic version of Xopenex news archive
Sepracor Inc. said a company is trying to make a generic version of its best-selling product, the asthma treatment Xopenex, and pledged to file a lawsuit to block the potential competition....
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12/09/2005  Lupin gets USFDA approval for Lisinopril Tablets news archive
Pharma major Lupin Ltd Tuesday said it has got approval from the US FDA of its Abbreviated New Drug Application (ANDA) for Lisinopril Tablets. ...
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13/09/2005  Novartis Unit Sues FDA Over Human Growth Hormone news archive
Sandoz, a unit of Swiss drugmaker Novartis, on Tuesday said it sued the U.S. Food and Drug Administration, seeking to force the agency to make a decision on its application to sell a generic human growth hormone....
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14/09/2005  Lannett Launches Generic Bactrim® news archive
Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has commenced marketing Sulfamethoxazole with Trimethoprim single strength (SS) and double strength (DS) tablets...
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14/09/2005  Mylan Announces Approval for Metformin Hydrochloride Extended-release Tablets, 500 mg and 750 mg news archive
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 Applications (ANDAs) for Metformin Hydrochloride...
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14/09/2005  Sanofi-Aventis: Arava® facing generic attack news archive
The FDA has granted several generics companies approval to market generic formulations of Sanofi-Aventis' disease-modifying rheumatoid arthritis drug (DMARD) Arava®. ...
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15/09/2005  Zentiva to Acquire Control of Sicomed news archive
Zentiva N.V. announced today the signing of an agreement for the acquisition of 51% of S.C. Sicomed S.A., the number 1 generics company in Romania via the acquisition of Venoma Holdings Limited for US$102 million in cash. ...
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15/09/2005  Lannett Company Launches Generic Estratest® and Syntest® news archive
Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced the launch of a combination drug product Esterified Estrogens with Methyltestosterone tablets in full and half strengths. ...
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16/09/2005  Fougera® Receives First Tentative Generic Approval For Metrogel® news archive
Fougera, a specialty manufacturer of dermatologic and ophthalmic pharmaceuticals, announced today that it has received tentative FDA approval to introduce the first generic version of Metronidazole Topical Gel USP 0.75%....
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16/09/2005  Lannett Launches Generic Cleocin® news archive
Lannett Company, Inc. a manufacturer of generic pharmaceuticals, today announced that it has commenced marketing Clindamycin capsules 75, 150 and 300 milligrams. ...
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16/09/2005  Taro Receives FDA Approval for Alclometasone Dipropionate Cream USP, 0.05% ANDA news archive
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16/09/2005  Ranbaxy Receives Final Approval From USFDA For Gabapentin Tablets news archive
Ranbaxy Laboratories Limited announced today that the Company has received approval from the U.S. Food and Drug Administration, Office of Generic Drugs, to manufacture and market Gabapentin Tablets, 600 and 800 mg strengths. ...
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18/09/2005  Teva Announces Tentative Approval of Ribavirin Tablets news archive
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s ANDA for Ribavirin Tablets, 200 mg. ...
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20/09/2005  Spear Pharmaceuticals Receives ANDA Approval For Tretinoin Cream news archive
Spear Pharmaceuticals is very pleased to announce the approval of Tretinoin Cream USP, .05% (Emollient) effective September 15, 2005. The Spear product is therapeutically equivalent to Johnson & Johnson Consumer Companies,...
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21/09/2005  Barr Confirms That Aventis and Albany Molecular Research, Inc. Are Seeking a Preliminary Injunction on AllegraR Tablets news archive
Barr Pharmaceuticals, Inc. today confirmed that Aventis Pharmaceuticals, Inc. along with Albany Molecular Research, Inc. have filed a motion for a preliminary injunction or expedited trial in the United States District Court for the District of New Jersey. ...
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23/09/2005  Taro Receives Approval For Mupirocin Ointment USP, 2% ANDA news archive
Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals U.S.A., Inc. has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Mupirocin Ointment USP, 2% (mupirocin ointment)....
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23/09/2005  Baxter Prevails in Sevoflurane Patent Dispute news archive
A ruling by Judge Ronald Guzman of the U.S. District Court for the Northern District of Illinois concluded an Abbott Laboratories patent related to sevoflurane combined with water was not infringed by Baxter's generic version of sevoflurane...
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23/09/2005  SICOR Introduces Pamidronate Disodium Injection news archive
SICOR Pharmaceuticals Sales, Inc. is pleased to announce the introduction and availability of Pamidronate Disodium Injection. This product has the same therapeutic effect as Aredia®* for Intravenous Infusion....
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27/09/2005  Nabi Biopharmaceuticals Files Lawsuit for Infringement of its PhosLo® Gelcap Patent news archive
Nabi Biopharmaceuticals announced today that it has filed a lawsuit against Roxane Laboratories, Inc. for infringement of its PhosLo® (calcium acetate) gelcap patent. The lawsuit was filed in the United States District Court for the Southern District of Ohio....
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28/09/2005  Spectrum Pharmaceuticals Receives FDA Approval for Fluconazole Tablets news archive
Spectrum Pharmaceuticals, today announced that today that it has received approval from the Office of Generic Drugs of the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) for fluconazole tablets....
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28/09/2005  Noven Provides Update On Developmental Fentanyl Patch news archive
Noven Pharmaceuticals, Inc., today announced that the U.S. Food & Drug Administration (“FDA”) has advised Noven that the FDA does not expect to approve Noven’s Abbreviated New Drug Application (ANDA) ...
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29/09/2005  IMPAX Prevails in Alza's Lawsuit Related to Generic Version of Ditropan news archive
IMPAX Laboratories, Inc. announced that it has prevailed in its defense of a lawsuit brought by Alza Corporation, a Johnson & Johnson unit, alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application...
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29/09/2005  Ranbaxy Gains Approval To Market Pseudoephedrine Hydrochloride Extended-Release Tablets news archive
Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg. ...
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30/09/2005  Actavis acquires KĂ©ri Pharma Generics news archive
Actavis Group, the international generic pharmaceutical company, today announces that it has acquired the generic business of the Hungarian pharmaceutical company, Kéri Pharma. Financial details were not disclosed....
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