Generics Industry News Search
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October 2004 News Archive |
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MIAMI - October 1, 2004 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) announced today that it has received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for fluoxetine capsules in a 40 mg dosage and fluoxetine tablets in a 40 mg dosage. Fluoxetine is the generic equivalent of Prozac®, which is marketed by Eli Lilly and used in the treatment of depression. ...
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MIAMI - October 1, 2004 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) announced today that it has received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for tizanidine HCl in 2 mg and 4 mg tablet dosages. ...
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MIAMI - October 1, 2004 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for brimonidine tartrate ophthalmic solution, 0.2%....
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Fort Lee, New Jersey…October 1, 2004…Alpharma Inc. (NYSE:ALO), a leading global generic pharmaceutical company, today announced that Purepac Pharmaceutical Co., a subsidiary of Alpharma, has received final approval from the United States Food and Drug Administration (FDA) for metformin hydrochloride extended-release tablets, 500 mg. This product is the generic equivalent of Glucophage XR, a product marketed by Bristol Myers, as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. ...
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Jerusalem, Israel, October 4, 2004 - 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 Ribavirin Capsules, 200 mg. Shipment of this product is expected to begin immediately....
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WOODCLIFF LAKE, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Warner Chilcott's Femhrt(R) (Norethindrone Acetate and Ethinyl Estradiol Tablets USP), 1 mg/0.005 mg....
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Fort Lee, New Jersey…October 8, 2004…Alpharma Inc. today announced that the District Court for New Jersey denied a request by Pfizer Pharmaceutical Co. ('Pfizer') for a temporary restraining order prohibiting sales of the company's gabapentin product. Earlier today, the company announced a launch of gabapentin capsules and Pfizer subsequently requested a temporary restraining order. The company continues to sell gabapentin capsules but is awaiting a decision by the District Court for New Jersey on a motion for a preliminary injunction filed by Pfizer seeking to enjoin the company's sales of gabapentin, which could impact continued sales of this product. ...
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Jerusalem, Israel, October 8, 2004 - 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 Gabapentin Capsules, 100 mg, 300 mg and
400 mg. Shipment of this product has commenced.
Gabapentin Capsules are the AB-rated generic equivalent of Pfizer's anticonvulsant, Neurontin® Capsules, which had annual sales of approximately $1.7 billion for the twelve months ended June 2004....
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Fort Lee, New Jersey…October 8, 2004…Alpharma Inc. today announced it has launched gabapentin capsules, 100 mg, 300 mg and 400 mg....
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NEW YORK, October 8, 2004 -- Greenstone Limited, a wholly owned subsidiary of Pfizer, announced today that it has launched a generic version of Pfizer's Neurontin (gabapentin). The new product will be distributed in 100 mg, 300 mg and 400 mg capsules....
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Venezuela and India have signed an agreement to produce and sell generic medication following an International South-South Cooperation & Medication Access Seminar to improve the life and health of the Venezuelan people....
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Hawthorne, New York, October 13, 2004 - Taro Pharmaceutical Industries Ltd. (Taro, Nasdaq: TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. (Taro USA), its U.S. affiliate, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Dipropionate Ointment (Augmented) USP, 0.05%....
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Jerusalem, Israel, October 13, 2004 - 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 Flumazenil Injection, 0.1 mg/mL....
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Fort Lee, New Jersey…October 13, 2004…Alpharma Inc. today announced that the District Court for New Jersey has denied a motion for a preliminary injunction filed by Pfizer Pharmaceutical Co. seeking to enjoin the sale of the company's gabapentin product....
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New Delhi - October 13, 2004 Ranbaxy Laboratories Limited (Ranbaxy) has decided to discontinue all its Rofecoxib formulations with immediate effect from India. Rofecoxib is currently being marketed by Ranbaxy also in Peru, Myanmar and Jordan, where it has a small marketshare. ...
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SCHAUMBURG, Ill., October 18, 2004 /PRNewswire-FirstCall -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Carboplatin for Injection, USP, the lyophilized form of carboplatin and the generic equivalent of Bristol-Myers Squibb Company's Paraplatin(R). ...
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Jerusalem, Israel, October 18, 2004 - 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 Cefuroxime Axetil Tablets USP, 250 mg and 500 mg. ...
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Prasco will market the first generic of PLETAL® (cilostazol) Tablets under the established name Cilostazol in 50 mg, and 100 mg strengths...
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WOODCLIFF LAKE, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market a generic version of Bristol Myers Squibb's Glucophage(R) XR (metformin hydrochloride extended-release tablets) 750 mg. ...
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Fort Lee, New Jersey…October 22, 2003…Alpharma Inc. today announced that Purepac Pharmaceutical Co., a subsidiary of Alpharma, has received final approval from the United States Food and Drug Administration (FDA) for gabapentin tablets, 600 mg and 800 mg....
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Spring Valley, New York, October 25, 2004 - Par Pharmaceutical Companies, Inc. today announced that it has entered into a licensing agreement with developer Nastech Pharmaceutical Company Inc. (Nasdaq:NSTK) to market a calcitonin-salmon nasal spray....
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Ranbaxy Laboratories Limited announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Carvedilol Tablets, 3.125mg, 6.25mg, 12.5mg and 25mg. ...
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Aurobindo Pharma Ltd, a vertically integrated pharmaceutical company based at Hyderabad, India, is pleased to announce that US FDA (U.S. Food and Drug Administration) has granted approval for its first Abbreviated New Drug Application (ANDA) for Mirtazapine tablets 7.5mg, 15mg, 30mg and 45mg....
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Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced that it has filed its second ANDA (Abbreviated New Drug Application) for an ophthalmic (eye care) product with the U.S. Food and Drug Administration (FDA) on behalf of FDC Ltd. ...
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American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of amiodarone hydrochloride injection in 50mg strength, 18mL multi-dose vials....
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Jerusalem, Israel, October 27, 2004 - 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 Finasteride Tablets USP, 5 mg...
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Jerusalem, Israel, October 27, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL pre-filled syringe. ...
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Eon Labs, Inc. (Nasdaq: ELAB) announced today that it received final approval for Citalopram HBr, the generic equivalent of Celexa(R)(a) tablets, in the same strengths as the brand, 10mg, 20mg and 40mg. The introduction of Citalopram HBr represents another first to market product for Eon Labs. The Company will begin shipping Citalopram HBr tablets immediately....
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Fort Lee, New Jersey…October 28, 2004…Alpharma Inc. (NYSE:ALO), a leading global generic pharmaceutical company, today announced that Purepac Pharmaceutical Co., a subsidiary of Alpharma, ...
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The filing of the second ANDA for an injectable product marks yet another achievement in the implementation of our generic strategy for two reasons, stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. We believe generic versions of injectable products represent a significant and underserved market opportunity characterized by higher barriers to entry and a need for high level product development and regulatory expertise. ...
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Hyderabad, India, October 29 2004: Dr. Reddy's Laboratories (NYSE: RDY) announced today that the U. S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Citalopram hydrobromide tablets 10 mg, 20 mg and 40 mg. The Company will commence the commercial marketing of this product immediately....
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