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December 2004 News Archive |
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Jerusalem, Israel, December 1, 2004 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today, further to its announcement dated August 17, 2004, that it has completed its cash acquisition, of Pfizer's Italian generic pharmaceutical marketing company, Dorom S.r.l., one of the largest suppliers of generic pharmaceuticals to the Italian retail market....
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WOODCLIFF LAKE, N.J., Dec 2, 2004 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has initiated the challenge of the patent listed by Eli Lilly and Company in connection with Eli Lilly's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg....
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WOODCLIFF LAKE, N.J., Dec 3, 2004 /PRNewswire-FirstCall via COMTEX/ -- 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 generic version of Bristol Myer Squibb's Videx(R) EC (Didanosine) Delayed-release Capsules, 200 mg, 250 mg and 400 mg. ...
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WEST CHESTER, Pa., Dec. 8 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) today learned that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of an abbreviated new drug application (ANDA) filed with a paragraph IV certification by Barr Laboratories, Inc. for a generic form of ACTIQ® (oral transmucosal fentanyl citrate) [C-II]....
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Jerusalem, Israel, December 10, 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 Oxycodone Hydrochloride Extended Release Tablets,...
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WOODCLIFF LAKE, N.J., Dec 13, 2004 /PRNewswire-FirstCall via COMTEX/ -- 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 Demeclocycline Hydrochloride Tablets USP, 150 mg & 300 mg, the generic equivalent of ESP Pharma's Declomycin(R) Tablets, 150 mg & 300 mg....
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative 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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Jerusalem, Israel, December 14, 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 Metformin Hydrochloride Extended Release Tablets, 750 mg. ...
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fluoxetine 40mg capsules. ...
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Jerusalem, Israel, December 15, 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 Tablets, 600 mg and 800 mg....
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Jerusalem, Israel, December 16, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Ranbaxy Pharmaceuticals Inc. announced today that Teva has begun commercially shipping Quinapril HCl Tablets, 5 mg, 10 mg, 20 mg and 40 mg, manufactured pursuant to Ranbaxy's ANDA No. 076607, which received final FDA approval. The product will be sold under the Teva label and marketed by Teva USA...
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New Delhi- December 17, 2004
Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Topiramate Tablets, 25 mg, 100 mg, and 200 mg. ...
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fluoxetine 40mg capsules. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Prozac 40mg capsules of Eli Lilly and Company. ...
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg and 20 mg/12.5 mg. ...
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Jerusalem, Israel, December 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 Rosiglitazone Maleate Tablets, ...
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HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 22, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the Company has begun commercial distribution of its Bupropion Hydrochloride 200mg Extended Release Tablets. ...
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PITTSBURGH, Dec. 23 /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 Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg. ...
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SUNRISE, Fla., Dec. 27 /PRNewswire/ -- Abrika Pharmaceuticals LLLP (Abrika) has been advised that Biovail Laboratories, Inc. (Biovail) has commenced a patent suit in the Federal District Court for the Southern District of Florida against the company in response to Abrika's abbreviated new drug application ...
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IRVINE, Calif., Dec. 27 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that it has filed its seventh ANDA (Abbreviated New Drug Application), fourth and last this year, with the U.S. Food and Drug Administration (FDA). ...
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Quinapril HCT, which produced in tablets in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths, is the generic name of Pfizer's Accuretic/Accuzide, approved to treat high blood pressure and sold in the same dosages.
Accuretic/Accuzide came off patent in Germany in April this year, but marketing authorisations were granted on 23 December in Germany. Actavis expects Quinapril HCT to be among the top 10 to 15 sellers of their Third Party sales division this year. Over 25 million tablets have been sold to date, so we expect Quinapril HCT to be a healthy contributor to our product portfolio. Our customers will be the first to bring this generic version to market. said Gudbjorg Edda Eggertsdottir, Chief Executive of Sales & Marketing, Third Party sales.
Actavis' Third Party sales division, which represents 39% of Actavis' sales (first nine months of 2004), has launched nine new products this year, including this one, and had four new market launches for products already marketed elsewhere: three in France and one in Hungary....
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