Generics Industry News Search
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March 2008 News Archive |
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NEW DELHI (AFP) — A landmark plea by an Indian drug firm for a "compulsory licence" to sell generic copies of patented drugs to poor countries will continue next month.
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MONTVALE, N.J., March 3 -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive....
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Fournier Laboratories Ireland Ltd (LFI) and Laboratoires Fournier S.A. (LFSA), wholly-owned subsidiaries of Solvay Pharmaceuticals, announced today that they have filed patent infringement court actions in the United States against Teva Pharmaceuticals....
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JERUSALEM--(BUSINESS WIRE)--Mar 4, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that its U.S. subsidiary has filed a lawsuit against the U.S. Food and Drug Administration ("FDA") seeking an order requiring the FDA to relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal(R) (Risperidone) Tablets....
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CORONA, Calif., March 4, 2008 -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc....
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Mumbai, March 5, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval
for the Company’s Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co’s Gemzar®,
gemcitabine injection....
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Duramed Pharmaceuticals has filed a patent infringement lawsuit against Watson Pharmaceuticals, part of its continuing battle with companies that want to market generic versions of its branded products.
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Perrigo Company today announced that its partner, Teva Pharmaceutical Industries Ltd. , has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
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IMPAX Laboratories, Inc. (OTC:IPXL) today announced that Pfizer Inc., Pharmacia & Upjohn Co. LLC, and Pfizer Health AB (collectively "Pfizer") have filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Detrol LA(R) 2mg and 4mg capsules. ...
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NEW YORK--(BUSINESS WIRE)--Pfizer Inc announced today that the Court of Appeals for the Federal Circuit has upheld the two main U.S. patents covering Celebrex, the company’s selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. The patents had been challenged by generic manufacturer Teva Pharmaceuticals USA....
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St. Louis, Mo. (March 10, 2008) Amerinet Inc., a leading national health care group purchasing organization, announced today a new generic pharmaceuticals program designed to reduce its members spending while maintaining a competitive portfolio of direct agreements with generic and branded pharmaceutical manufacturers....
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BANGKOK (Reuters) - Thailand's new government will override international patents on three cancer drugs, new Health Minister Chaiya Sasomsap said on Monday after a month of protests against his review of the controversial policy....
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Princeton, New Jersey, March 12, 2008 -- Sandoz today announced the introduction in the United States of Omnitrope™ Pen 5 with liquid cartridge, a new form of the first follow-on version of a previously approved recombinant biotechnology drug approved by the Food and Drug Administration....
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AstraZeneca today announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (ANDAs)....
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MONTVALE, N.J., March 12 -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Bristol-Myers Squibb Company's Taxol(R) (paclitaxel) Injection USP, 6mg/mL, packaged in 100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials....
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MUMBAI, India: 12-Mar-08-Strides Arcolab today announced its second ANDS approval from Health Canada for Tazo Pip Sterile Injection in three presentations....
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Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth....
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Hawthorn Pharmaceuticals, Inc. announced today the US Food and Drug Administration (FDA) approval of the company's Granisol(TM) (granisetron HCl) Oral Solution. Granisol(TM) is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol(TM) is the AA-rated equivalent of Roche's Kytril(R) Oral Solution.
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Mumbai: Denying a legitimate call for cheaper drugs by the Thailand government, French drug-multinational Sanofi-Aventis has reiterated that it will resort to legal options if Indian generic company, Cadila Healthcare Ltd pursues export orders for the cheap generic version of its patented heart drug clopidogrel to that country....
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Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
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An investigation by ConsumerLab.com of generic versions of the popular anti-hypertensive Toprol XL reveals that generics sold by two companies appear to differ from the original drug in how they dissolve and in their inactive ingredients...
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Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3%. ...
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TALLAHASSEE -- Attorney General Bill McCollum announced Tuesday that Florida and 18 states have filed an antitrust lawsuit against Abbott Laboratories and French drug company Fournier Industrie et Sante and Laboratories Fournier, S.A.
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Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company today announced that it has launched ciprofloxacin injection, USP, 5% dextrose premix bag, a synthetic broad spectrum antimicrobial agent for intravenous (I.V.) administration used to treat bacterial infections. ...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection.
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Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials....
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MUMBAI, March 21, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, benzonatate capsules.
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the Food and Drug Administration (FDA) granted tentative approval to two fixed-dose combination products containing generic versions of stavudine/lamivudine/nevirapine 30mg/150mg/200mg Tablets, and stavudine/lamivudine/nevirapine 40mg/150mg/200mg Tablets, under expedited procedures for the President's Emergency Plan for AIDS Relief ...
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Pfizer Inc said today that the Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy Laboratories Limited from obtaining approval for a competitor product to Lipitor....
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HAWTHORNE, N.Y., March 25, 2008 -- Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Injection USP, 2 mg/mL ("Ondansetron Injection")....
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Advent International, a leading global buyout firm, has completed the acquisition of LaborMed Pharma from its founders. LaborMed, based in Bucharest, manufactures and distributes generic pharmaceuticals, primarily for cardiovascular and central nervous system ailments....
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Indian generic statin (cholesterol reducing drugs) manufacturers continue to face margin pressures in the regulated international market though they have overcome the worst they had faced earlier in the decade in some parts of it....
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LONDON, March 26 (Reuters) - It is crunch time for AstraZeneca's blockbuster schizophrenia drug Seroquel but many analysts think a generic version may not hit the key U.S. marketplace just yet.
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Actavis has received two separate approvals from the US Food & drug administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately....
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Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Bethanechol Chloride Tablets ...
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of New Jersey has granted Eisai's motion for a preliminary injunction related to Teva's tentatively approved Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept(R) (Donepezil Hydrochloride) Tablets...
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In a move that could stop Ranbaxy Laboratories Ltd from marketing the generic versions of Lipitor and Caduet, Pfizer lodged a judgement suit claiming Ranbaxy's proposed generic would infringe two patents related to atorvastatin, the active ingredient in Lipitor.
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Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic Amifostine for injection 500mg, which is therapeutically equivalent to MedImmune's Ethyol....
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Lannett Company, Inc. a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Rifampin Capsules in 150 mg and 300 mg, the generic equivalent of Rifadin Capsules marketed by Sanofi Aventis US, LLC....
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Bentley Pharmaceuticals, Inc. (NYSE: BNT) announced today that they have entered into a definitive agreement under which Teva will acquire Bentley. The acquisition will take place following the spin-off of Bentley's drug delivery business to its shareholders, which Bentley announced on October 23, 2007....
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Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey....
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Takeda Pharmaceutical Co. and Abbott Laboratories won a ruling that will prevent Teva Pharmaceutical Industries Ltd. from selling a generic version of the heartburn drug Prevacid until May 2009....
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