Generics Industry News Search
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November 2004 News Archive |
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PITTSBURGH, Nov. 2 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Loxapine Capsules, 5 mg, 10 mg, 25 mg, and 50 mg strengths. Loxapine Capsules are the generic version of Watson Laboratories, Inc.'s Loxitane(R) Capsules.
The product will be shipped immediately....
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The GPhA today commended the U.S. Food and Drug Administration for publishing its guidance document that clarifies certain aspects of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), calling the document generally consistent with the overall goals of the Act. ...
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Exeter, NH and Allegan, MI, Nov. 3, 2004 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceuticals and drug delivery company, and Perrigo Company (Nasdaq: PRGO), the nation's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market, announced today that they have entered into a product development, license and manufacturing agreement. ...
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PITTSBURGH, Nov. 9 /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 Pioglitazone Hydrochloride Tablets, 15 mg, 30 mg, and 45 mg.
Pioglitazone Hydrochloride Tablets are the generic version of Takeda Pharmaceuticals' Actos(R) Tablets....
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PITTSBURGH, Nov 19, 2004 /PRNewswire-FirstCall via COMTEX/ -- Mylan Laboratories Inc. (NYSE: MYL) confirmed that it received a letter from Carl Icahn and stated that it would respond in due course....
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Jerusalem, Israel, November 21, 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 Fosphenytoin Sodium Injection...
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Eon Labs, Inc. (Nasdaq: ELAB) announced today that it received final approval for Cilostazol 100mg tablets, the generic equivalent of Pletal(R)(a) 100mg tablets. The Company will begin shipping Cilostazol 100mg tablets immediately....
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Jerusalem, Israel, November 24, 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 Cilostazol Tablets, 50 mg and 100 mg. Shipment of this product is expected to begin immediately.
Teva's Cilostazol Tablets are the AB-rated generic equivalent of Otsuka's Pletal® Tablets, a product indicated for treatment of intermittent claudication.
The brand product has annual sales of approximately $178 million....
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MIAMI - November 24, 2004 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) confirmed that earlier this month, IVAX, in collaboration with its marketing and distribution partner, Combino Pharm SL, was first to market an injectable paclitaxel alternative to Bristol-Myers Squibb's anti cancer drug, Taxol® in Spain. IVAX' proprietary injectable paclitaxel has the brand name Paxene® in the European Union. ...
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30 NOVEMBER 2004 | GENEVA -- The World Health Organization (WHO) is reinstating two antiretrovirals manufactured by Cipla Ltd., India, in its list of prequalified medicines. The two medicines (which are used in the treatment of AIDS) had been delisted by WHO in May this year due to non-compliance with international standards at the contract research organizations (CROs) hired by Cipla to conduct bioequivalence tests on the products....
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Jerusalem, Israel, November 30, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today a number of management promotions, as well as the addition of new executive talent to its management team....
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