Generics Industry News Search
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April 2005 News Archive |
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New Delhi - April 01, 2005 Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Nitrofurantoin Monohydrate/Macrocrystals Capsules, 100 mg. 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 Macrobid®....
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Jubilant Organosys Ltd, a composite pharmaceuticals industry player, has signed a Memorandum of Understanding (MoU) to acquire 75% of the equity in a generic pharmaceutical company in USA....
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TORONTO, Apr 04, 2005 (BUSINESS WIRE) -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that a United States District Judge for the District of Columbia has granted Biovail's motions for summary judgment, thereby dismissing complaints in two related putative class-action cases asserting antitrust claims by purchasers of Biovail's Tiazac(R) product....
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Eon Labs, Inc. (Nasdaq: ELAB) announced that it received final approval today of Nitrofurantoin Monohydrate/Macrocrystals 100mg capsules, the generic equivalent to Macrobid(R)* capsules. The Company will begin shipping the product immediately....
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Aspen Pharmacare Holdings Limited (Aspen), Africa's largest pharmaceutical manufacturer and leading supplier of generics today announced that it has signed Memorandums of Understanding (MOUs) with Indian based Matrix Laboratories Limited (Matrix) to strengthen Aspen's vertical integration into the manufacture of Active Pharmaceutical Ingredients (APIs)....
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ALLEGAN, Mich. – April 11, 2005 – The Perrigo Company (Nasdaq: PRGO; TASE: PRGO) today announced that its Agis Industries subsidiary has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Mometasone Furoate Topical Solution USP, 0.1% (Lotion).
The product is the AB-rated equivalent to Schering-Plough’s Elocon® Topical Lotion, indicated for the relief of inflammatory skin conditions. Annual sales for the brand are approximately $10 million. Agis was the first applicant to file a complete ANDA with a Paragraph IV certification and has been granted 180 days of market exclusivity....
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Sun Pharmaceutical Industries is to acquire the entire business of fellow Indian pharmaceutical company MJ Pharmaceuticals in another example of the consolidation affecting the country's fragmented pharmaceutical sector, writes Phil Taylor....
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Jerusalem, Israel, April 13, 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 Metformin Hydrochloride Extended Release Tablets, 750 mg. Shipment of this product is expected to begin immediately.
Teva's Metformin HCl ER Tablets, 750 mg, are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage® XR Tablets, 750 mg, a product indicated for the treatment of type 2 diabetes.
Total annual sales of this product, including brand and generic sales, are approximately $28 million....
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April 13, 2005--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for metformin hydrochloride extended-release tablets, 750mg. Andrx has already commenced shipping this product.
Andrx's metformin HCl ER tablets, 750mg, are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage(R) XR Tablets, 750mg, a product indicated for the treatment of type 2 diabetes....
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INDIANAPOLIS, April 14, 2005 /PRNewswire-FirstCall via COMTEX/ -- The U.S. District Court for the Southern District of Indiana today upheld Eli Lilly and Company's (NYSE: LLY) 2011 patent on Zyprexa®, a breakthrough medicine for the treatment of schizophrenia and bipolar disorder. In the case of Eli Lilly and Company v....
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HAWTHORNE, N.Y., Apr 14, 2005 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (NASDAQ: TARO) 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 Ciclopirox Olamine Cream USP, 0.77% (ciclopirox cream)....
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Fort Lee, New Jersey…April 15, 2005…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 for metformin hydrochloride extended-release tablets, 750 mg. ...
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Dr. Reddy's Laboratories (NYSE: RDY) announced today that the United States District Court for the Southern District of Indiana has issued an opinion following the completion of a trial on Eli Lilly's U.S. Patent No. 5,229,382 relating to Zyprexa® and found the patent to be valid. ...
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MIAMI - April 18, 2005 - IVAX Corporation (AMEX: IVX, LSE: IVX.L, WSE: IVX) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for anagrelide HCl capsules in 0.5 and 1 mg dosage strengths....
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HAYWARD, Calif.--(BUSINESS WIRE)--April 18, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXLE) 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 Agrylin(R) (Anagrelide Hydrocloride) HCI 0.5 and 1.0 mg capsules....
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LAKE SUCCESS, N.Y.--(BUSINESS WIRE)--April 18, 2005--Eon Labs, Inc. (Nasdaq: ELAB) announced today that it received final approval for Anagrelide HCl capsules, the generic equivalent of Agrylin(R)* capsules, in the same strengths as the brand, 0.5mg and 1mg. The Company will begin shipping Anagrelide HCl capsules immediately.
*Agrylin(R) is a registered trademark of Shire US, Inc. which is not affiliated with Eon Labs, Inc....
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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 Vinorelbine Tartrate Injection, 10 mg (base)/mL, the generic equivalent of GlaxoSmithKline's Navelbine®. ...
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Philadelphia, PA - April 21, 2005 - Lannett Company, Inc. (Amex: LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Tablets 37.5mg. ...
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Spring Valley, New York, April 22, 2005 - Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that its wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for tramadol hydrochloride (HCl) and acetaminophen tablets....
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WOODCLIFF LAKE, N.J., April 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced the U.S. Food and Drug Administration (FDA) has issued a Not Approvable letter for Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Bijuva(TM) (Synthetic Conjugated Estrogens, A) Cream....
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Apr 27, 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 Clozapine Tablets, 25 mg and 100 mg. Shipment of this product is expected to begin immediately.
Teva's Clozapine Tablets are the AB-rated generic equivalent of Novartis' antipsychotic agent Clozaril(R) Tablets.
Total annual sales of this product, including brand and generic sales, are approximately $183 million....
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WOODCLIFF LAKE, N.J., April 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food & Drug Administration (FDA) for its generic version of Kos Pharmaceutical, Inc.'s (Kos) Niaspan(R) 500 mg, 750 mg and 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablets). The final approval follows the expiration of Kos' 30-month stay under the Hatch-Waxman patent challenge provisions and the resolution of the litigation between Barr and Kos regarding the Niaspan products....
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ALLEGAN, Mich. - April 28, 2005 - The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market prescription Naproxen Tablets USP, 250 mg, 375 mg and 500 mg.
The product is the AB-rated equivalent to Roche's Naprosyn® Tablets, indicated for the treatment of arthritis, tendonitis, bursitis and for the relief of mild to moderate pain. Sales for the brand and generics were approximately $100 million in 2004....
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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, announced today that one of its Spanish subsidiaries, Laboratorios Davur, has received approval to market 1 mg, 3 mg and 6 mg generic dosage versions of risperidone in Spain....
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SCHAUMBURG, Ill., April 29, 2005. American Pharmaceutical Partners, Inc. , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Adenosine Injection, USP, 3 mg/mL, packaged in 6 mg/2mL and 12mg/4mL single use vials, the generic equivalent of Fujisawa's Adenocard® Injection....
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