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   March 2005 News Archive news archive  


01/03/2005  IVAX Receives Final Approval on Cilostazol Tablets 100 Mg news archive
MIAMI - March 1, 2005 - IVAX Corporation (AMEX: IVX, LSE: IVX.L, WSE: IVX) has received a final approval from the U.S. Drug and Food Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cilostazol tablets, 100 mg This product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Cilostazol tablets, 100 mg is the generic equivalent of Pletal® Tablets, which is marketed by Otsuka American Pharmaceutical, Inc. for intermittent claudication (pain in the legs that happens when walking and goes away with rest). According to IMS data, U.S. sales of cilostazol tablets, 100 mg were $154.2 million for 2004....
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02/03/2005  IMPAX Receives Final FDA Approval for Generic Version of Dantrium; Global Division to Launch Immediately news archive
HAYWARD, Calif.--(BUSINESS WIRE)--March 2, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application for a generic version of Dantrium(R) (Dantrolene Sodium) 25, 50 and 100 mg Capsules....
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03/03/2005  Impax Launches Generic Version of OxyContin Controlled Release 80 mg Tablets news archive
HAYWARD, Calif.--(BUSINESS WIRE)--March 3, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) has begun commercial distribution of its generic version of OxyContin(R) (Oxycodone Hydrochloride) Controlled Release 80 mg Tablets. ...
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09/03/2005  IMPAX Announces Biovail's Lawsuit Related to Generic Versions of Wellbutrin XL news archive
HAYWARD, Calif.--(BUSINESS WIRE)--March 9, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that Biovail Laboratories Inc., a subsidiary of Biovail Corporation (NYSE:BVF) (TSX:BVF), has filed a lawsuit against the Company in the United States District Court, Eastern District of Pennsylvania (Philadelphia), alleging patent infringement related to IMPAX's filing for a generic version of Wellbutrin XL(R). ...
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09/03/2005  Barr Confirms Kos Is Seeking Court Order to Block Potential Launch of Generic NiaspanR news archive
WOODCLIFF LAKE, N.J., March 9, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) has filed a motion for a temporary restraining order and a preliminary injunction in the United States District Court for the Southern District of New York seeking to prevent Barr from launching generic versions of Kos' Niaspan(R) 500 mg, 750 mg and 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablets) following final U.S. Food & Drug Administration (FDA) approval....
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09/03/2005  Zydus Cadila announces alliance with Mallinckrodt to Market Generics in USA news archive
Zydus Cadila's US subsidiary, Zydus Pharmaceuticals (USA) Inc. has entered into a strategic alliance with Mallinckrodt Pharmaceuticals Generics, a business unit of Tyco Healthcare and one of the top ten Generics companies in the US....
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09/03/2005  EPO Rules Symbicort Combination Patent Still Valid news archive
AstraZeneca today announced that the European Patent Office (EPO) has ruled that the European combination patent for Symbicort® is still valid, despite a challenge by several generic manufacturers....
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11/03/2005  Sanofi-aventis sues Novopharm for patent infringement in Canada news archive
PARIS, March 11 /CNW Telbec/ - Sanofi-aventis has learned through the Canadian Ministry of Health website that Novopharm Limited had obtained marketing approval in Canada for a product claiming to be generic enoxaparin.

Sanofi-aventis companies Aventis Pharma Inc. and Aventis Pharma S.A. are bringing suit in the Federal Court against Novopharm for patent infringement of Canadian patent 2045433, which covers Lovenox(R). Sanofi-aventis will vigorously defend its legal rights with respect to this patent....
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16/03/2005  Orchid inks development and supply agreement with STADA Pharmaceuticals, Inc. USA for six products in the US market news archive
The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid), today announced that it has entered into an exclusive agreement with STADA Pharmaceuticals, Inc. (STADA), the U.S. subsidiary of STADA Arzneimittel AG, for the development and supply of six prescription generic drug products to STADA for the US market. ...
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17/03/2005  Teva Announces Settlement Of Lamictal® Litigation With Glaxosmithkline news archive
Jerusalem, Israel, February 17, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has settled patent litigation with GlaxoSmithKline relating to lamotrigine, the generic version of GlaxoSmithKline's Lamictal®....
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17/03/2005  Perrigo Company Completes Acquisition of Agis Industries news archive
Creates global provider of generic prescription drugs, active pharmaceutical ingredients and consumer healthcare products . ALLEGAN, Mich. - March 17, 2005 - The Perrigo Company (Nasdaq: PRGO) today announced the completion of its acquisition of Agis Industries (1983) Ltd., a developer and manufacturer of specialized generic pharmaceuticals and active pharmaceutical ingredients (API)....
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23/03/2005  IVAX Launches Gabapentin Capsules news archive
MIAMI - March 23, 2005 - IVAX Corporation (AMEX: IVX, LSE: IVX.L, WSE: IVX) launched its AB-rated gabapentin capsules in 100 mg, 300 mg and 400 mg dosage strengths. Gabapentin is the generic equivalent of Neurontin® a drug used to treat epileptic seizures which is marketed by Warner-Lambert, a unit of Pfizer Inc. According to IMS data, for the fourth quarter 2004, U.S. sales of Neurontin® and gabapentin in 100, 300 and 400 mg dosage strengths were $337 million. ...
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24/03/2005  Teva Anounces Approval Of Methylprednisolone Acetate Injectable Suspension news archive
Jerusalem, Israel, February 24, 2005 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Methylprednisolone Acetate Injectable Suspension, 40 mg/mL and 80 mg/mL in single dose vials....
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27/03/2005  Teva Announces Tentative Approval Of Amlodipine Besylate Tablets news archive
Jerusalem, Israel, March 27, 2005 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Amlodipine Besylate Tablets, 2.5 mg, 5 mg and 10 mg. ...
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28/03/2005  Glenmark Pharma and Shasun Sign Development and Marketing Agreement for the US Market news archive
March 28, 2005: Glenmark Pharmaceuticals Ltd and Shasun Chemicals and Drugs Ltd have entered into a collaboration agreement for the joint development, filing and marketing of twelve generic pharmaceutical products for the US market. The product list includes a mixture of off-patent and patent-protected molecules with cumulative annual sales in the US of about USD 8 Bn....
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28/03/2005  Dr. Reddy's and ICICI Venture announce USD 56 million-partnership for the commercialization of ANDAs news archive
Dr. Reddy's unique initiative to partner with India's largest private equity investor for pipeline expansion for the U.S. Generics market.

Dr. Reddy's to leverage global scale and infrastructure for pipeline expansion....
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29/03/2005  Austrian Patent Office Issues Favourable Ruling for Ranbaxy on Atorvastatin news archive
New Delhi - March 29, 2005. Ranbaxy Laboratories Ltd (Ranbaxy) today announced that it successfully invalidated claims 1-3 (all claims sought to be invalidated) of Austrian Patent No. AT E 207 896 as anticipated by, and as lacking inventive step over, respectively, a Pfizer-owned published patent application and a Pfizer owned patent, as reflected by a decision released by the Austrian Patent Office....
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29/03/2005  Barr Confirms Filing an Application With a Paragraph IV Certification for YasminR news archive
WOODCLIFF LAKE, N.J., March 29, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany in connection with Berlex's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive. Yasmin is a low-dose, monophasic oral contraceptive and the first birth control pill to contain the progestin, drospirenone....
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29/03/2005  Mylan Receives Tentative Approval for Olanzapine Tablets news archive
PITTSBURGH, March 29 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Olanzapine Tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths. Olanzapine Tablets are the generic version of Eli Lilly and Company's Zyprexa(R) Tablets, which has annual U.S. sales of approximately $2.8 billion....
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30/03/2005  Barr and PLIVA Sign Agreement to Develop and Market Generic Version of G-CSF in United States and Canada news archive
WOODCLIFF LAKE, N.J., March 30, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) and PLIVA d.d. (LSE: PLVD, ZSE: PLVA-R-A) today announced that Barr's subsidiary, Barr Laboratories, Inc., and PLIVA's subsidiaries, PLIVA Croatia Ltd. and PAM Kft., have entered into a development, supply and marketing agreement for the generic biopharmaceutical Granulocyte Colony Stimulating Factor (G-CSF). ...
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30/03/2005  Barr and Kos in Settlement Discussions Regarding NiaspanR Patent Litigation news archive
Court Agrees to Discontinue Further Proceedings to Allow Parties to Negotiate Definitive Agreement

WOODCLIFF LAKE, N.J. and CRANBURY, N.J., March 30 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) and Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) today announced that Barr Laboratories, Inc. and Kos are engaged in discussions to settle the outstanding patent litigation regarding Kos' Niaspan(R) product. ...
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30/03/2005  Ranbaxy to Appeal Preliminary Injunction Against Sales of Quinapril news archive
New Delhi - March 30, 2005. Ranbaxy Laboratories Limited (Ranbaxy) announced today that the U.S. District Court for the District of New Jersey hearing the preliminary injunction motion brought by Pfizer against Teva Pharmaceuticals USA, Inc. (Teva) and Ranbaxy Pharmaceuticals Inc. (RPI) enjoined Teva and RPI from selling RPI's quinapril tablets (5, 10, 20, and 40 mg)....
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31/03/2005  Barr Says Court Rejects Ciprofloxacin Antitrust Class Action Suits news archive
WOODCLIFF LAKE, N.J., March 31 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. District Court for the Eastern District of New York has granted summary judgment in the Company's favor and rejected a challenge to the lawfulness of its 1997 settlement with Bayer Corporation of patent litigation related to the antibiotic Cipro(C). ...
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