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August 2006 News Archive |
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Amneal Pharmaceuticals LLC (United States) partners in the success
MUMBAI, Aug. 1, 2006--Granules India Ltd. and Amneal Pharmaceuticals LLC (United States) are pleased to announce the approval of the ANDA of Metformin Hydrochloride tablets of 500 mg, 850 mg and 1000 mg. This is the first time that the FDA has approved an ANDA with a PFI (Pharmaceutical Formulation Intermediate) - DMF as a raw material....
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WOODCLIFF LAKE, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market a generic version of Pfizer Inc.'s XANAX XR(R) (Alprazolam Extended-Release) Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg....
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TORONTO--(BUSINESS WIRE)--Aug. 2, 2006--Biovail Corporation announced today that on August 1, 2006, in the United States District Court for the Central District of California, Judge James V. Selna issued an order granting Anchen Pharmaceutical Inc.'s (Anchen) Motion for Summary Judgment on the Wellbutrin XL(R) patent-infringement case, and denied it on the invalidity issue....
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From Orange Book Blog - www.OrangeBookBlog.com
The FDA recently posted ViroPharma, Inc.'s scientific supplement to its citizen petition asking FDA to stay approval of generic Vancocin (vancomycin hydrochloride). Vancocin is ViroPharma's orally administered tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis that is approved for treatment of colitis caused by susceptible bacteria. There are no unexpired patents or other exclusivities available for Vancocin....
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Johnson & Johnson's Alza drug unit sued Wyeth (Alza Corporation v. Wyeth, Wyeth Pharmaceuticals, Inc. Case No. 9:06-cv-00156-RHC), saying that Effexor XR infringes a patent for a method of administering antidepressants.
Effexor is Wyeth's biggest product and the world's best-selling antidepressant....
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TOKYO, August 3, 2006 - DAIICHI SANKYO COMPANY, LIMITED announces that SANKYO COMPANY, LIMITED (President: Ikegami, Yasuhiro; hereinafter Sankyo), a wholly owned subsidiary of DAIICHI SANKYO COMPANY, LIMITED, and its U.S. subsidiary, DAIICHI SANKYO, INC. (New Jersey, hereinafter DSI), commenced litigation against Mylan* in the United States District Court for the District of New Jersey for infringement of Sankyo’s U.S. patent (hereinafter Patent) covering olmesartan medoxomil, the active ingredient in Sankyo’s antihypertensive drug, Benicar®....
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Supports Call for Immediate Release of FDA Guidance on Generic Insulin, HGH
ARLINGTON, Va., August 03, 2006 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today applauded Governors Kathleen Sebelius (D-Kan.), Tim Pawlenty (R-Minn.), James H. Douglas (R-Vt.) and Jim Doyle (D-Wis.) for filing a citizen petition with the U.S. Food and Drug Administration (FDA) seeking immediate release of agency guidance that would pave the way for introduction of more affordable, generic versions of Insulin and Human Growth Hormone (HGH). The citizen petition was filed earlier today....
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TOKYO, August 3, 2006 – DAIICHI SANKYO COMPANY, LIMITED (President & CEO: Takashi Shoda) and its wholly owned subsidiary, Daiichi Pharmaceutical Co., Ltd. (President: Kiyoshi Morita), announced today that Daiichi has prevailed in a patent infringement litigation in which Apotex was seeking the right to sell a generic version of Daiichi’s antibiotic ear drop medicine FLOXIN® Otic....
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THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug 3, 2006 - Amgen today issued the following statement:
The Court of Appeals for the Federal Circuit today affirmed the District Court's decision that Transkaryotic Therapies Inc. (TKT) and Aventis Pharmaceuticals Inc. infringe Amgen's erythropoietin (EPO) patent estate....
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CAFC Overturns Earlier District Court Ruling On The Same Patent
Gurgaon, India, August 03, 2006 - Ranbaxy Laboratories Limited (Ranbaxy) announced today that the U.S. Court of Appeals for the Federal Circuit (CAFC) handed down a judgment in its case challenging two key atorvastatin patents held by Pfizer. Atorvastatin is a cholesterol-lowering drug, marketed by Pfizer as Lipitor®, and is the largest-selling drug in the world with estimated annual sales in the U.S. of USD 8.5 Bn (IMS - MAT: March 2006)....
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Jerusalem, Israel, August 4, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride Tablets, 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg. Shipment of this product will begin immediately....
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On August 4, Fitzpatrick filed a complaint in the United States District Court for the District of New Jersey on behalf of Plaintiffs Wyeth and Altana Pharma AG (Altana) against defendants Kudco Ireland, Ltd., Kremers Urban Development Co., Shwarz Pharma, Inc., Shwarz Pharma USA Holdings, Inc. and Shwarz Pharma AG. The lawsuit involves a generic patent challenge to Wyeth and Altana's hugely successful, multibillion dollar drug product, Protonix(tm). Protonix(tm) is prescribed for heartburn and gastroesophageal reflux disease or GERD, and is Altana's biggest drug product....
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Tokyo, Japan and Teaneck, New Jersey, August 4, 2006 - Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) today announce that they have filed a lawsuit against Mutual Pharmaceutical Co., Ltd. and United Research Laboratories, Inc. regarding its submission of an abbreviated new drug application (ANDA) to the FDA for Aricept ODT® Orally Disintegrating Tablets (Active Ingredient Name: donepezil hydrochloride). Eisai's action was filed in the U.S. District Court for the District of New Jersey in Newark on August 3, 2006....
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PRINCETON, N.J., August 04, 2006 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Risperidone Oral Solution, 1 mg/mL....
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From Orange Book Blog - www.OrangeBookBlog.com
Abbott Laboratories and Teva Pharmaceuticals have settled their Biaxin XL patent infringement litigation in the U.S. District Court for the Northern District of Illinois. Biaxin XL is an extended release formulation of clarithromycin used to treat bacterial respiratory infections, with over $1 billion in annual sales....
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ALLEGAN, Mich., August 07, 2006 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that its partner, InvaGen Pharmaceuticals, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) on its ANDA for Terbinafine Hydrochloride Tablets, 250 mg (base)....
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Peania, August 7, 2006. - Lavipharm S.A. announces the approval to market its generic fentanyl transdermal system from the FDA (Food and Drug Administration), the US healthcare regulator. The product has been developed by Lavipharm Laboratories, Inc., the Group's Research and Development arm in the USA....
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Consumers Have Immediate Access to an Affordable Version of this Important Product.
Weston, FL (August 8, 2006) — Apotex Corp. announced that it has today launched clopidogrel bisulfate 75 mg tablets. Clopidogrel is the generic equivalent of Sanofi's Plavix®, which is marketed in the U.S. by Bristol Myers Squibb....
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PARIS, Aug. 8, 2006- Sanofi Aventis today provided an update regarding the Plavix patent infringement case filed by sanofi-aventis and Bristol Myers Squibb Company against Apotex Inc. and Apotex Corp.
For the full release please click on the link below....
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Paris, France, August 10, 1006 - Sanofi-aventis announced today that after the positive outcome of the appeal for sanofi-aventis, the Lovenox(R) patent infringement case against Amphastar and Teva was remanded to the U.S. District Court for the Central District of California and assigned to a new judge....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Aug 10, 2006 - Akorn, Inc. today announced that it has signed a definitive exclusive development and supply agreement to develop and commercialize an ANDA drug product. Sofgen Pharmaceuticals is a privately held pharmaceutical company located in Sunrise, Florida....
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FORT LEE, New Jersey, August 14, 2006 -- DAVA Pharmaceuticals, Inc. announced today that it will be the exclusive marketer and distributor of Lavipharm Laboratories’ Fentanyl transdermal system in the United States. Lavipharm, the U.S. subsidiary of Greek pharmaceutical leader Lavipharm S.A., received final approval from the U.S. Food and Drug Administration for its Fentanyl 25mg/h, 50mg/h, 75mg/h and 100mg/h transdermal systems on August 4, 2006....
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Form Strategic Development Partnership on Six Proprietary Products
WOODCLIFF LAKE, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary Duramed Pharmaceuticals, Inc. and Shire plc have signed a Product Acquisition Agreement for ADDERALL(R) (immediate-release mixed amphetamine salts) tablets and a Product Development Agreement for six proprietary products, and that its subsidiary Barr Laboratories, Inc. (Barr) has signed a Settlement and License Agreement relating to the resolution of two pending patent cases involving Shire's ADDERALL XR(R)....
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TORONTO, Ontario--(BUSINESS WIRE)--Aug 14, 2006 - Gilead Sciences, Inc. today announced that the company has signed non-exclusive license agreements to provide generic versions of tenofovir disoproxil fumarate (sold by Gilead under the brand name Viread(R)) to three generic manufacturers in India. These license agreements grant to Emcure Pharmaceuticals Ltd., Hetero Drugs Ltd. and Strides Arcolab Ltd. the rights to produce and distribute generic versions of tenofovir to 95 low-income countries around the world, including India....
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PITTSBURGH, August 14, 2006 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Venlafaxine Hydrochloride Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base)....
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MUMBAI, Aug. 14, 2006--Strides Arcolab today announced that it has received tentative approval from the United States Food and Drug Administration for Nevirapine Tablets 200mg. This is the company's first ANDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief [PEPFAR] program....
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NORTH WALES, Pa., Aug. 16, 2006 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Sertraline Hydrochloride Tablets. This product is AB rated and bioequivalent to Zoloft®* Tablets. Sertraline Hydrochloride Tablets are available in 25 mg, 50 mg and 100 mg strengths in bottle sizes of 30 tablets and unit-dose boxes of 100 tablets....
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DETROIT, August 16, 2006 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Baclofen Tablets....
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From Duncan Bucknell - www.DuncanBucknell.com (Pfizer Inc. v Ranbaxy Laboratories CAFC 06-1179 (2006))
Take home
The US Court of Appeals for the Federal Circuit has now confirmed that a patent claim can be invalidated on what was previously considered to be a minor technical defect. (Basically, a dependant claim is invalid if it is not a subset of the claim from which it purports to depend.)...
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Aurobindo Pharma Limited is pleased to announce that it has received the marketing authorization approval from UK MHRA (United Kingdom Medicines and Healthcare products Regulatory Agency) for Mirtazapine 15, 30 and 45 mg Tablets containing the active ingredient Mirtazapine....
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ZymoGenetics, Inc. filed an infringement suit against Bristol-Myers Squibb over its patents related to fusion protein technology. The lawsuit, ZymoGenetics, Inc. v. Bristol-Myers Squibb Co., et al., District Court of Delaware, is for injunctive relief and damages over infringement, contributory infringement and/or inducement of infringement of US Patent Nos. 5,843,725 and 6,018,026....
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New York, August 17 - Pfizer Inc said today that a federal court jury in the Eastern District of Virginia (Alexandria) has ruled unanimously that Pfizer does not infringe Synthon IP’s U.S. patent covering a process for making amlodipine, the active ingredient in Norvasc. Norvasc is the world’s most-prescribed branded medicine for treating hypertension....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Aug 17, 2006 - Akorn, Inc. (AMEX:AKN) today announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of FDC Limited (FDC). Akorn and FDC announced the signing of a purchase and supply agreement in July 2004....
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PHILADELPHIA, August 18, 2006 /PRNewswire/ -- United Research Laboratories and Mutual Pharmaceutical Company today announce that Mutual has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), seeking approval to market Mutual's guaifenesin extended-release tablets, 600 mg and 1200 mg. Guaifenesin extended-release tablets are currently marketed over-the-counter by Adams Respiratory Therapeutics under the brand name Mucinex(R). According to Adams, Mucinex(R) is one of the most widely recommended OTC products to treat chest congestion and related coughs....
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Ranbaxy Laboratories Limited today announced the launch of its brand Soliten (Solifenacin), in the Indian market for the management of chronic urological disorder. The product is being introduced for the first time in India. Soliten will be sold in dosage forms of 5 mg and 10 mg tablets....
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Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) today announced that it has received the formal approval from the USFDA for 3 of its ANDAs (Abbreviated New Drug Applications) for Cefotaxime for injection in various dosage forms. These pertain to 500mg, 1gm and 2gm single-dose vials, 1gm and 2gm piggyback vials and 10gm pharmacy bulk package vials....
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Approved in Canada as Monotherapy in Early PD and as an Adjunct to Levodopa in Moderate-to-Advanced Disease
Jerusalem, Israel, August 21, 2006 - Teva Pharmaceutical Industries Ltd. announced today that AZILECT® (rasagiline tablets), the first once daily oral treatment for Parkinson's disease (PD) has just been approved by Health Canada....
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SAINTE-FOY, QUEBEC - August 24, 2006 - Bioxel Pharma Inc., a leading manufacturer and supplier of taxane APIs and developer of targeted oncology drugs, is pleased to announce that it has begun commercial deliveries of cGMP paclitaxel to one of the largest European generic company, pursuant to the terms of the supply agreement executed in October, 2005....
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TORONTO--(BUSINESS WIRE)--Aug. 24, 2006 - Biovail Corporation today announced that it has filed suit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Columbia. Biovail's legal action refers to its Citizen Petition filed with the FDA on December 20, 2005....
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Mumbai, August 24, 2006: Glenmark Pharmaceuticals, Inc., USA [GPI], the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited [Glenmark], received US FDA approval to market Gabapentin oral tablets 600 mg and 800 mg. Gabapentin belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures. It is also widely used to relieve different kinds of pain and even psychiatric disorders. The drug enjoys a generic market size of USD 328 million....
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ROCKVILLE, Md., Aug. 24, 2006--The Food and Drug Administration (FDA), on August 23, 2006, granted tentative approval for a fixed dose tablet containing lamivudine/zidovudine 150 mg/300 mg manufactured by Pharmacare Limited of South Africa. The tablets are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Aug. 25, 2006--Akorn-Strides, LLC, a joint venture company formed between Akorn, Inc. and Strides Arcolab Limited, today announced that it has submitted its tenth Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs....
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If you're familiar with the drug industry, it should come as no great shock that the Generic Pharmaceutical Association (GPhA) disagrees with a report put out by the Pharmaceutical Research and Manufacturers of America (PhRMA)....
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PITTSBURGH and HYDERABAD, India, Aug. 28 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. and Matrix Laboratories Ltd. (Mumbai Stock Exchange, 524794; National Stock Exchange, MATRIXLABS) today announced that Mylan will acquire up to 71.5% of Matrix shares outstanding for Rs. 306 per Matrix share. Under the terms of the transaction, Mylan will purchase 51.5% of Matrix's shares outstanding pursuant to an agreement with certain selling shareholders and will make an open offer to Matrix's remaining shareholders to acquire up to an additional 20% of Matrix's shares outstanding....
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GENT, Belgium- MADISON, Wisconsin, August 29, 2006 – On Monday 28 August 2006, the Court case, wherein Innogenetics NV has asserted that Abbott Laboratories has infringed its patent on HCV genotyping, started in front of the District Court of the Western District of Wisconsin, USA. In defense, Abbott has asserted that the Innogenetics U.S. patent is invalid....
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IRVINE, Calif., Aug. 28, 2006 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Ciprofloxacin Injection, USP. This product is AP rated to Cipro®* I.V. for Intravenous Infusion. Ciprofl oxacin Injection is available in 200 mg, 1% and 400 mg, 1% single dose vials....
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CHADDS FORD, Pa., Aug. 28 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc., a market leader in pain management, announced today that it has reached an agreement with The Purdue Frederick Company, The P.F. Laboratories, Inc., and Euro-Celtique, S.A. to settle long-running litigation claiming that Endo's oxycodone extended-release tablets, 10mg, 20mg, 40mg, and 80mg, a bioequivalent version of Purdue Frederick's OxyContin(R), infringe Purdue's U.S. Patent Nos. 5,549,912, 5,508,042 and 5,656,295....
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BEDFORD, OH, Aug. 28, 2006 – Bedford Laboratories™, a division of Ben Venue Laboratories Inc., has announced that it will begin marketing Ciprofloxacin Injection USP as of August 28, 2006. This product is AP rated and is equivalent to Cipro I.V. ® by Bayer. Ciprofloxacin Injection USP is a synthetic broad-spectrum antimicrobial agent that is indicated in the prevention or treatment of infections that are proven or strongly suspected to be caused by bacteria....
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Three of Four Patent Rulings Now Favor Ranbaxy
PRINCETON, N.J., August 29, 2006 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL) announced that a Norwegian court today handed down a favorable decision for Ranbaxy in its case against Pfizer, involving two patents on atorvastatin in Norway. Atorvastatin is a cholesterol-lowering drug which is marketed by Pfizer as Lipitor(R)....
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MUMBAI, India, Aug. 29 2006 - Strides Arcolab today announced that it has received tentative approval from the United States Food and Drug Administration for Stavudine Capsules USP, 30mg and 40mg. This is the company's second ANDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief [PEPFAR] program....
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PITTSBURGH, Aug. 30 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Fluoxetine Capsules, USP, 10mg and 20mg....
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Jerusalem, Israel, August 31, 2006 - Teva Pharmaceutical Industries Ltd. announced today that it has signed an agreement with The Purdue Frederick Company and certain of its affiliates to settle patent infringement litigation pertaining to Teva's generic version of Purdue's OxyContin® (oxycodone HCl extended-release) Tablets pending in the United States District Court for the Southern District of New York....
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Reykjavik, Iceland, 31 August 2006 - Actavis Group, the international generic pharmaceutical company, today announces that it has increased its offer to acquire the Croatian pharmaceutical company, PLIVA d.d, to HRK795 per share in cash.
For further details please click on the link below....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Aug. 31, 2006--Akorn, Inc. today announced that it has signed a Commercial Manufacturing Supply Agreement with GeneraMedix Inc., a privately held pharmaceutical company that develops, markets and sells generic injectable pharmaceutical products....
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Apotex To Halt Sales Of Unauthorized Generic
Paris, France and New York, New York (August 31, 2006) -- Sanofi-aventis and Bristol-Myers Squibb today announced that the U.S. District Court for the Southern District of New York has granted a preliminary injunction ordering Apotex Inc. and Apotex Corp. (Apotex) to halt its sales of a generic version of clopidogrel bisulfate product that competes with PLAVIX®....
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