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   March 2008 News Archive news archive  


01/03/2008  Key drug hearing to continue in March: Indian officials news archive
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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03/03/2008  Barr Announces Favorable Ruling in YasminR Patent Challenge news archive
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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03/03/2008  Fournier Laboratories Ireland Ltd and Laboratoires Fournier SA filed patent infringement actions against Teva in the USA news archive
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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04/03/2008  Teva Provides Update on Generic Risperdal news archive
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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04/03/2008  Watson Files Application for Generic SeasoniqueR news archive
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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05/03/2008  Sun Pharma gets USFDA tentative approval for generic Gemzar® injection news archive
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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05/03/2008  Duramed sues Watson Pharmaceuticals over drug patent news archive
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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06/03/2008  Perrigo Company to Market Over-the-Counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets news archive
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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06/03/2008  IMPAX Comments on Lawsuit Related to Generic Version of Detrol LA news archive
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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08/03/2008  Pfizer Wins Challenge to Two Main U.S. Patents for Celebrex by Generic Manufacturer Teva news archive
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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10/03/2008  Amerinet Launches Generic Sourcing Program to Reduce Pharmacy Spend news archive
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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10/03/2008  Thailand will override cancer drug patents news archive
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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12/03/2008  Sandoz enhances patient access with launch of Omnitrope™ Pen 5 news archive
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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12/03/2008  Trial Date Set For SEROQUEL® Patent Litigation news archive
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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12/03/2008  Barr Receives Approval for Generic TaxolR Injection USP, 6mg/mL news archive
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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12/03/2008  Strides Arcolab Receives Health Canada Approval for Tazo Pip Injection news archive
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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13/03/2008  Watson Files FDA Application for Generic Lybrel news archive
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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13/03/2008  Hawthorn Pharmaceuticals, Inc. Receives FDA Approval on Granisol Oral Solution news archive
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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13/03/2008  Sanofi in talks with Thai govt to protect its patent right news archive
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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14/03/2008  Want Generic Biotech? You Might Wait 14 More Years news archive
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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17/03/2008  As Problems Surface, Consumerlab.com and the People’s Pharmacy Ask FDA to Disclose Differences Between Generic and Original Drugs news archive
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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18/03/2008  Hi-Tech Pharmacal Receives Final Approval for Ofloxacin Otic Solution news archive
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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19/03/2008  Florida suing company for blocking generic drug competition news archive
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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19/03/2008  Sagent Pharmaceuticals Launches Ciprofloxacin Injection, USP, 5% Dextrose Premix Bag news archive
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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19/03/2008  Sun Pharmaceutical announces USFDA approval to market generic Cerebyx news archive
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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19/03/2008  Strides Arcolab receives its third injectable ANDA approval for Fosphenytoin Injection 50mg/mL news archive
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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21/03/2008  Sun Pharmaceutical Announces USFDA Approval to Market Generic Tessalon news archive
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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24/03/2008  HIV/AIDS Update - Tentative Approval of Two Fixed Dose Combination Products for PEPFAR news archive
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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24/03/2008  Federal Court of Appeal in Canada Upholds Lipitor Enantiomer Patent, Decision Prevents Launch of Generic Product by Ranbaxy until 2010 news archive
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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25/03/2008  Taro Receives FDA Approval for Ondansetron Hydrochloride Injection USP, 2 mg/mL ANDA news archive
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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25/03/2008  Advent International acquires its second generics company news archive
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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26/03/2008  Statins remain under margin pressure news archive
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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26/03/2008  AstraZeneca's Seroquel may dodge generics, for now news archive
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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28/03/2008  Actavis Receives Approval of Generic Wellbutrin SR and Zyban Tablets in the U.S news archive
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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28/03/2008  Lannett Company Receives FDA Approval for Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg, and 50 mg news archive
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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28/03/2008  Teva Provides Update on Generic Aricept Litigation news archive
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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28/03/2008  Pfizer sues Ranbaxy to extend Lipitor patent by six years news archive
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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31/03/2008  Sun Pharmaceutical announces launch of generic Ethyol news archive
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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31/03/2008  Lannett Company Receives FDA Approval for Rifampin Capsules USP, 150 mg and 300 mg news archive
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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31/03/2008  Teva to Acquire Bentley Pharmaceuticals news archive
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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31/03/2008  Bayer appeals invalidity ruling on its Yasmin Patent news archive
Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey....
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31/03/2008  Takeda, Abbott Win Prevacid Patent Ruling Over Teva news archive
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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