Generics Industry News Search
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October 2010 News Archive |
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application to market a generic version of Orion's Stalevo tablets...
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Johnson & Johnson has warned certain sales representatives to be prepared for layoffs due to the possible launch of generic copies of its blockbuster drug for attention-deficit disorder, according to a person who was on a sales-force conference call last month...
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Mylan Inc today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bupropion Hydrochloride Extended-release Tablets USP, (XL), 150 mg and 300 mg (Once-Daily), the generic version of GlaxoSmithKline's antidepressant Wellbutrin XL....
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Endo Pharmaceuticals is buying the privately-held generic pain medications giant Qualitest from Apax Partners for about $1.2 billion...
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Teva Pharmaceutical subsidiary Teva UK has launched a generic version of Cosopt, Teva Pharmaceutical announced in a press release....
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Mylan Inc today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia...
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Pharma Major, Lupin Limited announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. has been granted final approval for the company's generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium) by the U.S. Food and Drug Administration...
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Teva Pharmaceutical Industries Ltd.'s Neutroval failed to receive first-round approval in the US with the Food and Drug Administration recently issuing a complete response letter for the company's Biologic License Application for the candidate...
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Strides Arcolab Limited today announced that it has received its 50th USFDA ANDA approval with approvals for the following two products:
- Lidocaine Hydrochloride Injection USP, 20 mg/mL (preservative-free), packaged in 100 mgs/5 mL single-use vials
- Lidocaine Hydrochloride Injection USP, 0.5% (5mg/mL) & 1% (10mg/mL), packaged in single-use vials....
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its Abbreviated New Drug Application for Atazanavir Sulfate Capsules, 150 mg and 300 mg....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market rasagiline mesylate 0.5 and 1.0 mg tablets....
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Jazz Pharmaceuticals, Inc. today announced that the website of the US Food and Drug Administration indicates that an Abbreviated New Drug Application for a generic version of Xyrem (sodium oxybate oral solution) 500 mg/ml was submitted on July 8, 2010....
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Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release oral suspension...
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Quebec drugstore giant Jean Coutu Group Inc. said yesterday its topline is feeling the pinch from wider introduction of generic versions of big-volume drugs in the past year...
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A recent rise in non-communicable diseases is largely associated with changing lifestyles. The diseases are blamed for the surge in mortality rates linked to lack of...
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Teva Pharmaceutical Industries Ltd., the biggest generic-drug maker, can challenge patents on Eisai Co's Alzheimer's treatment Aricept, a U.S. appeals court ruled....
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Glenmark Pharmaceuticals S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, announced today that it has been granted by Lay Line Genomics S.p.A. an exclusive, worldwide license to LLG's entire intellectual property portfolio in the TrkA field. The licensed assets include BXL1H5 which is a novel monoclonal antibody that binds to TrkA receptors. This represents another first-in-class opportunity for Glenmark....
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. has reached a settlement with Endo Pharmaceuticals, Inc. on outstanding patent litigation related to Endo's Opana(R) ER (Oxymorphone ER) product....
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Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced the US Food and Drug Administration has approved first-ever generic of TUSSIONEX, an Extended-Release Suspension containing hydrocodone polistirex and chlorpheniramine polistirex. ...
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The drug seizure agreement with the European Union may be an eyewash as another international treaty will allow 40 countries to seize in transit generic medicines...
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With the rising costs of healthcare premiums and prescriptions, many people look at their spending for ways to cut back. One way is to switch to generic prescriptions rather than name brands...
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Drug firm Glenmark Pharmaceuticals today said it has received approval from US health regulator to sell generic Pramipexole Dihydrochloride tablets, used for treating Parkinson's Disease, in the American market....
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An arm of Citigroup and two other investors are mulling a sale of copycat drugmaker Biofarma, people familiar with the matter said, in what could be Turkey's biggest healthcare deal.
The generic drugmaker, whose full name is Biofarma Pharmaceutical Industry Co Inc, has met investment bankers and is close to picking advisers to help prepare the company for a $500 million-plus sale, these people added. One said it could be worth nearly $1 billion...
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Bristol-Myers Squibb Company announced today that it has completed its previously announced acquisition of ZymoGenetics, Inc.. As a result of the transaction, ZymoGenetics has become a wholly-owned subsidiary of Bristol-Myers Squibb. ...
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H. Lundbeck A/S and Merck, known outside the U.S. and Canada as MSD, today announced a worldwide commercialization agreement for SYCREST sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan....
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Stocks have dropped considerably for drug rx company Alexza, whose pivotal medication AZ-004 was denied approval by the FDA this week. The drug, which contains staccato loxapine to help combat the effects of bipolar disorder and schizophrenia, was designed to be administered with a plastic inhaler....
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Despite the approval of a generics pathway over a year ago, not a single generic version of ViroPharma's VPHM Clostridium difficile infection therapy Vancocin has entered the market. We are placing ViroPharma under review, and we plan to moderately increase our fair value estimate to account for longer-than-anticipated exclusivity for this highly profitable drug...
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Cohen Pontani Lieberman & Pavane LLP, a preeminent intellectual property litigation firm, has won a major jury verdict on all counts in its defense of its generic drug client, Sandoz Inc....
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Os laboratorios farmaceuticos estao fazendo de tudo para prejudicar os consumidores brasileiros, avidos por comprar remedios mais baratos - muitos, de uso continuo....
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A generic version of the weight-loss drug Meridia will be voluntarily pulled from the Canadian market, Health Canada says....
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Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Losartan Potassium Tablets...
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Zydus Cadila has launched Pramipexole tablets (0.125 mg, 0.25 mg, 0.5 mg, 1 mg, 1.5 mg) in the US market upon patent expiry. ...
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Watson Pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules...
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Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration has approved Questcor's supplemental new drug application for H.P. Acthar Gel (repository corticotropin injection) in the treatment of infantile spasms, an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for the generic versions of Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg, both antihypertensives....
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Pharma major Dr Reddy's Laboratories (DRL) today said it will soon be launching its generic drug Lansoprazole in the US market...
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Bags right to sell another drug that was not even part of the litigation.
Drug major Lupin's patent litigation settlement with Warner Chilcott has paved way for a new business model in the patent litigation battles in the US...
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Meridia was taken off the market due to the risk to those who have a history of heart disease. Now a generic version of the drug is gone, too.
Just days after the prescription weight-loss drug Meridia, also known as sibutramine, was taken off the market in the U.S. and Canada due to risk for people with a history of heart disease a generic version of the drug called Apo-sibutramine has also been pulled from the shelves
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Biocon, Asia's premier biotechnology company, and Pfizer Inc., the world's leading biopharmaceutical company, today announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro. ...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application to market a generic version of Takeda's Prevacid (lansoprazole) SoluTab....
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Intellipharmaceutics International Inc. today announced that the Food and Drug Administration has accepted for filing its abbreviated new drug application for a generic version of Protonix (delayed release pantoprazole sodium). ...
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has commenced shipping Fluphenazine HCl Tablets USP, the generic equivalent of Prolixin, in 1 mg, 2.5 mg, 5 mg and 10 mg dosages....
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Sandoz today announced the introduction of lansoprazole delayed-release orally disintegrating tablets, an authorized generic equivalent of Prevacid SoluTab, in the US. ...
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(Company believes court erred in its decision)
Mylan Inc. today announced that its motion for a preliminary injunction against GlaxoSmithKline and Apotex pertaining to generic Paxil CR was denied at a hearing today in the U.S. District Court for the District of New Jersey....
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Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced.
As the first company to file an ANDA that contained a paragraph IV certification for Ambien CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product....
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Pfizer Inc., the world's largest drugmaker, said Wednesday it will pay about $240 million upfront to enter a partnership with a Brazilian drugmaker to develop and sell generic drugs.
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Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration for marketing the Fexofenadine HCl 60mg + Pseudoephedrine HCL 120mg extended release tablets which is used for treatment of seasonal allergic rhinitis without causing drowsiness. ...
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K-V Pharmaceutical Company today announced the establishment of a new generic marketing subsidiary, Nesher Pharmaceuticals, Inc. and the appointment of Mark Hartman as its President....
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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, over the next decade, the epilepsy drug market will remain relatively flat, increasing from $2.8 billion in 2009 to $2.9 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan. ...
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Cephalon, Inc. announced today that it has exercised its option to acquire BioAssets Development Corporation, following receipt of interim data from a Phase II placebo-controlled proof-of-concept study evaluating epidural administration of a tumor necrosis factor inhibitor for the treatment of sciatica in 45 patients. Sciatica is a neuropathic inflammatory pain condition that occurs when the sciatic nerve is compressed, injured or irritated. As part of the acquisition, Cephalon will gain rights to the BDC intellectual property estate covering the use of cytokine inhibitors, including TNF inhibitors, for sciatic pain in patients with intervertebral disk herniation, as well as other spinal disorders. The transaction is expected to close in mid-November. ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex Tablets, a Parkinson's disease treatment. ...
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Sandoz today announced the launch of piperacillin and tazobactam for injection, a generic equivalent of Zosyn, in the US. Piperacillin and tazobactam for injection is an antibacterial treatment indicated for use in adults with certain types of moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam susceptible, β-lactamase producing strains....
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Apotex Inc., the largest Canadian-owned pharmaceutical manufacturer, has been hit with a $442 million fine by Judge Sidney H. Stein of the U.S. District Court, Southern District of New York (Manhattan) for patent infringement against Sanofi-Aventis and its partner Bristol-Myers, regarding its marketing of a generic version of Plavix (clopidogrel), a drug widely used during and after angioplasty and stent placement...
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the launch of piperacillin and tazobactam for injection in the United States. The medication is a generic version of Zosyn, the world's leading injectable antibiotic, from Pfizer. Piperacillin and tazobactam injection posted 2009 U.S. sales of more than $855 million. ...
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Driven by growth in generics segment Dr Reddy's Laboratories, India's second largest drug maker, registered a 32 per cent increase in net profit that grew to R287 crore at the end of September quarter 2010, against R217 crore of the same quarter previous year...
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The US Food and Drug Administration has warned that it is considering tightening controls on generic drugs so that there is "less variability" with their brand-name counterparts....
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Dr. Reddy's Laboratories has entered into an agreement with Cipla limited for exclusive marketing rights of a portfolio of OTC and prescription products in the Russian and Ukraine markets. As per the agreement, Dr. Reddy's has initiated the sales and promotion of the portfolio of products from Q2 FY11 in select therapy areas in Russia. Launch in Ukraine to take place next calendar year. ...
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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV. Shire had previously reported in March 2010 of the receipt of a Paragraph IV Letter from Teva Pharmaceuticals USA, Inc. and in April 2010 of a Paragraph IV Letters from Actavis Elizabeth LLC and Anchen Pharmaceuticals, Inc., both regarding ANDAs for generic versions of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets....
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Australia's competition watchdog postponed a decision on Aspen Pharmacare's A$900 million bid for Sigma Pharmaceuticals' generic drugs division, saying it could reduce competition...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed a new drug application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act with the U.S. Food and Drug Administration seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets....
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Teva Pharmaceutical Industries Ltd. and Merck Serono, a division of Merck KGaA announced today that they have entered into a definitive agreement under which Teva will acquire Theramex and related companies from Merck Serono....
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Astellas Pharma Inc. and its US affiliate Astellas US LLC jointly filed a patent infringement lawsuit in the United States against Nycomed US Inc. in response to its submission of an abbreviated new drug application for a generic version of Astellas 0.1% tacrolimus ointment, which is sold under the trademark Protopic....
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SOHM, Inc. a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories announced today that the Company is negotiating to partner with a global efficiency firm headquartered in India. The firm will assist with managing soaring growth in India, Sri Lanka, Southeast Asia, Africa, Mexico and Latin America...
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Baxter International Inc. announced today that it has entered into a definitive agreement to divest its U.S. generic injectables business to Hikma Pharmaceuticals PLC. The consideration for the divestiture arrangement totals approximately $112 million, subject to closing adjustments. The sale of this business will allow Baxter to redirect resources toward its proprietary, enhanced packaging offerings and formulation technologies, consistent with the company's focus on product differentiation. Baxter expects to record an after-tax special charge in the third quarter of approximately $70 million (or $0.12 per diluted share), principally to write down the assets of the business....
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The Italian Antitrust Authority (Autorita Garante della concorrenza e del mercato) announced on 26 October that it commenced proceedings against Pfizer following a complaint filed by Ratiopharm alleging that Pfizer's behaviour in the enforcement of its patent rights amounts to abuse of a dominant position. ...
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AS AN emerging hub for high quality affordable generic products, the Ministry of Commerce and Industry of the Government of India recently sent delegates to the Philippines to explore business opportunities for its pharmaceutical exports...
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Chairman Dilip Shanghvi: Though Taro provides a platform to expand generic opportunities, the organization requires a significant and sustained rebuilding effort...
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