Generics Industry News Search
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February 2007 News Archive |
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NEW YORK, Jan. 31 /PRNewswire-FirstCall/ -- The federal district court in the Eastern District of Virginia (Alexandria) has ruled that Synthon IP obtained, by inequitable conduct, two U.S. patents alleged to cover a process and an intermediate compound used to make the active ingredient in Pfizer's widely-prescribed hypertension medication, Norvasc, Pfizer said today....
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The year 2006 can be regarded as a landmark year in Canadian intellectual property (IP) law, due to the breadth and scope of the decisions and legislative changes affecting rights holders in the field of patent, trade-mark and copyright law. Many of these changes reflect the international scope and the prevailing influence of the Internet and other electronic media on IP protection and enforcement. As these developments will continue to have an impact on IP rights holders in 2007 and beyond, Fasken Martineau's Intellectual Property Group is pleased to provide a synopsis of the significant changes involving IP law for the past year....
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Senator Herb Kohl (D-WI) has introduced S. 448, "The Fair Prescription Drug Act of 2007," which would ban the sale of authorized generic drugs during a ANDA applicant's 180-day exclusivity period. The bill is cosponsored by Senators Rockefeller (D-WV), Schumer (D-NY), and Leahy (D-VT). The same bill was proposed last year as S. 3695. Senator Kohl believes the bill has a good chance of being passed....
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Undeterred by the Supreme Court's denial of its cert petition in Apotex v. Pfizer last year, Apotex has filed yet another lawsuit asserting that listing a patent in the Orange Book establishes a justiciable controversy and therefore declaratory judgment jurisdiction. This argument failed at least twice before, in Teva v. Pfizer (relating to generic Zoloft) and Apotex v. Pfizer (concerning generic Accupril). This time around, Apotex is targeting GlaxoSmithKline and its antiulcer medication Zantac Syrup (ranitidine HCl)....
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PRINCETON, N.J., February 01, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to market Valacyclovir Hydrochloride tablets, 500 mg (base) and 1 g (base)....
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LYSAKER, Norway, Feb. 1, 2007: The county administrative court (Länsrätten) in Uppsala, Sweden, has rejected the complaint from Pfizer regarding the status of Navamedic ASA's Glucomed and Recip's Glucosine as generic substitutions to Pfizer's Artrox....
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In a long-awaited decision that affirmed the validity of Eli Lilly’s patent on its top-selling Zyprexa®, the U.S. Court of Appeals for the Federal Circuit upheld a district court’s April 2005 ruling on issues that included anticipation, obviousness and public use. Eli Lilly and Company v. Zenith Goldline Pharmaceuticals Inc., Case Nos. 05-1396, -1429, -1430 (Fed. Cir., Dec, 26, 2006) (Rader, J.)....
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/Orchid/ Chennai, India – February 01, 2007 -- The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd., (Orchid), today announced that it has entered into a licensing and distribution agreement with the international generic pharmaceuticals company Actavis for marketing 9 of Orchid’s cephalosporin generic formulations in Europe, comprising all the EU (European Union) and CEE (Central & Eastern Europe) countries, numbering 37 in total.
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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced its latest product launch and marketing approvals in the European Union (EU). John Sedor, president of Bentley commented, "These approvals and product launch are consistent with our expansion strategy to increase our product portfolio in Spain while also accelerating our efforts into other EU markets."...
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DUBLIN, Ireland--(BUSINESS WIRE)--Feb 2, 2007 - Research and Markets (http://www.researchandmarkets.com/reports/c49747) has announced the addition of "Par Pharmaceutical Generics Company Intelligence Report" to their offering. ...
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As we previously reported, last year a jury in the Eastern District of Virginia found that Pfizer does not infringe Synthon IP, Inc.'s patent on processes for making the active ingredient in Norvasc (amlodipine besylate) and also that the patent is invalid. Now, following a bench trial in the same court, Judge T.S. Ellis III has dealt a final blow to Synthon by finding its patents unenforceable due to inequitable conduct. ...
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MISSISSAUGA, ON, February 02, 2007 /PRNewswire-FirstCall/ - DRAXIMAGE, the radiopharmaceutical division of DRAXIS Health Inc. , has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for its generic kit for the preparation of Tc-99m Sestamibi for injection (DRAXIMAGE(R) Sestamibi), a nuclear medicine imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart in patients undergoing cardiac tests. ...
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PHILADELPHIA and LONDON, February 02, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline today issued an update on US patent litigation regarding Valtrex (valacyclovir), an antiviral drug used for the treatment and suppression of genital herpes, herpes zoster (shingles), and cold sores....
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Chennai-based Orchid Chemicals & Pharmaceuticals Ltd. along with two other generic manufactures --- Sandoz and Abraxis Pharmaceutical Products sued Wyeth for unfairly delaying the entry of generic versions of blockbuster Zosyn in the US market....
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WOODCLIFF LAKE, N.J., February 06, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. and its subsidiary PLIVA d.d. today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Sertraline Hydrochloride Tablets, 25 mg, 50 mg and 100 mg, generic versions of Pfizer Inc.'s ZOLOFT(R) Tablets. ...
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PITTSBURGH, February 06, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg....
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ROCKVILLE, Md., Feb. 6, 2007--The Food and Drug Administration (FDA), on January 31, 2007, granted tentative approval for a fixed-dose, three-drug tablet for use as a complete anti-viral treatment of human immunodeficiency virus (HIV-1) infection in adults. The tablet contains lamivudine-zidovudine-nevirapine, the active ingredients in the widely used antiretroviral drugs Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine). The new combination tablet is manufactured by Cipla Limited, of Mumbai, India. ...
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ARLINGTON, Va., February 06, 2007 /PRNewswire-USNewswire/ -- Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger today released the following statement regarding the Bush Administration's Fiscal Year 2008 budget proposal: ...
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Judge Colleen Kollar-Kotelly of the U.S. District Court for the District of Columbia recently denied Barr Laboratories' motion to dismiss a Federal Trade Commission lawsuit stemming from Barr's agreement with Warner Chilcott concerning generic Ovcon 35. The opinion is available here....
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COLUMBUS, Ohio, February 07, 2007 /PRNewswire/ -- Roxane Laboratories, Inc. today announced the launch of Sertraline Hydrochloride Tablets, 25mg, 50mg, 100mg. The product will be available in bottles of 30 and 480....
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BALTIMORE, February 07, 2007 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg. Commercial shipments of the product have commenced....
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REYKJAVIK, Iceland, February 07, 2007 /PRNewswire/ -- Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Sertraline Hydrochloride tablets. Distribution of the product will commence immediately. ...
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NORTH WALES, Pa, Feb.7, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Trandolapril Tablets. This product is AB rated and bioequivalent to Mavik Tablets. Trandolapril Tablets are available in 1 mg, 2 mg and 4 mg strengths, in bottles of 100 tablets....
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Canberra, Australia (AHN) - Health minister Tony Abbott has announced that he will investigate claims that pharmaceutical companies are purposely creating shortages of generic brands. ...
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PITTSBURGH, Feb. 8 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sotalol Hydrochloride Tablets USP (AF), 80mg, 120mg and 160mg. ...
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PRINCETON, N.J., February 08, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), and 200 mg (base)....
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Abbott Laboratories lost its challenge to a generic-drug company's proposed immediate-release version of the antibiotic drug Biaxin. ...
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Sanofi-Aventis SA, France's biggest pharmaceutical company, and Canadian drugmaker QLT Inc. agreed to pay a total of $157.5 million to end a patent suit so they can continue to sell the prostate cancer drug Eligard. ...
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In a ruling issued last Friday, Judge Mariana R. Pfaelzer of the U.S. District Court for the Central District of California held Aventis’s U.S. Patent No. 5,389,618 and its U.S. Reissue Patent No. 38,743 unenforceable due to inequitable conduct. The patents cover Lovenox (enoxaparin), a low-molecular weight heparin composition exhibiting anticoagulant properties and indicated for the prevention and treatment of deep vein thrombosis....
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ST. LOUIS, February 12, 2007 /PRNewswire-FirstCall/ -- Generic anti-cholesterol drugs helped pharmacy benefit manager Express Scripts save $126 million for its plan sponsors and patients in 2006. ...
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CORONA, Calif., February 12, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with GlaxoSmithKline on outstanding patent litigation related to Wellbutrin XL(R) (bupropion hydrochloride) extended-release tablets 150mg. ...
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Ranbaxy Laboratories Limited (Ranbaxy), today launched the generic Atorvastatin in Denmark....
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A federal judge in New Jersey ruled in favor of Johnson & Johnson in a dispute over its patent for epilepsy drug Topamax, blocking a bid by Mylan Laboratories Inc. to sell a generic form of the drug....
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LONDON, February 13, 2007 /PRNewswire/ -- An ageing population and rising drug costs are underlining the increasingly critical role of cost-effective generic medicines. Simultaneously, the highly competitive generics industry is pressurising the mainstream pharmaceutical sector to develop innovative drugs. ...
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ARLINGTON, Va., February 14, 2007 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today expressed its strong support for bipartisan legislation to bring safe, effective and affordable biogenerics to consumers. With countless Americans struggling to afford these life-saving medicines, "The Access to Life-Saving Medicine Act" will create a safe, clear and efficient abbreviated Food and Drug Administration (FDA) approval pathway so patients can have timely access to biogenerics....
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REYKJAVIK, Iceland, February 14, 2007 /PRNewswire-FirstCall/ -- Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Alprazolam ER tablets. Distribution of the product will commence in coming weeks. ...
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Ranbaxy Laboratories Limited (RLL) announced today the signing of a global development & marketing agreement with Zenotech Laboratories Ltd for its first biosimilar product, G-CSF (filgrastim). ...
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ST. LOUIS--(BUSINESS WIRE)--Feb 15, 2007 - Generic biotech medicines could save U.S. plan sponsors and patients $71 billion over ten years, with $3.5 billion of the savings occurring the first year, according to a report issued by Express Scripts, one of the nation's largest managers of pharmacy benefit plans. ...
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Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. While generic drugs have been extremely successful in bringing down the high cost of prescription drugs, there is currently no FDA pathway for getting approval for biogenerics....
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The Senate Judiciary Committee passed the "Preserve Access to Affordable Generics Act" (S. 316) today by unanimous consent. If enacted, the bill would prohibit "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company pays a generic drug company to delay marketing its generic drug product....
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PITTSBURGH, February 16, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Propranolol Hydrochloride Extended-release (ER) Capsules, USP in 60mg, 80mg, 120mg and 160mg strengths. ...
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Actavis announced today that it has acquired the API (Active Pharmaceutical Ingredient) division of Sanmar Specialty Chemicals Ltd (SSCL), a subsidiary of the Sanmar Group based in Chennai, Southern India. The acquisition price is not disclosed. ...
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Thailand is likely to widen its use of cheaper, generic versions of patented drugs, unless western drug companies cut the prices of their original medications, the country's health minister has said....
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A Budapest court rejected Merck & Co.'s patent-infringement case against Gedeon Richter Nyrt's Sedron osteoporosis medicine, reaffirming an appellate court ruling from one year ago....
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Ranbaxy Inc., said today that federal officials conducted a search at its New Jersey offices on Feb 14, 2007....
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20 Feb 2007 - Basingstoke, UK and Philadelphia, PA, US – February 20, 2007- Shire plc announces today that it has agreed to acquire New River Pharmaceuticals Inc. for $64 per New River share, or approximately $2.6 billion in total, in an all cash transaction unanimously recommended by the Boards of both companies....
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It has always been assumed that the answer is "yes." Now the Federal Circuit will answer the question directly in Merck v. High-Tech Pharma., which concerns High-Tech's ANDAs for generic versions of Merck's Trusopt and Cosopt prescription eye drops. The case was argued in December and a decision could come at any time....
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Nedlands-based pharmaceutical company PharmAust Ltd has signed a five-year distribution contract for five generic prescription medicines to the Australian market, the company announced today....
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NEW YORK, February 21, 2007 /PRNewswire-FirstCall/ -- China Aoxing Pharmaceutical Company, Inc. , a pharmaceutical company based in China that has developed a patented manufacturing process for a variety of generic analgesic drugs, including Oxycodone, Pholcodine, Naloxone, and Tilidine, today announced the product launch of Naloxone Hydrochloride ("Naloxone") in China....
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Gurgaon, India, February 21, 2007 - This refers to the News Item titled “Promoters may sell 7% in Ranbaxy” in the Economic Times dated February 21, 2007 suggesting that the Promoters of Ranbaxy Laboratories Limited – Malvinder and Shivinder Singh families may sell a small portion of their equity to Private Equity (PE) firms in order to raise money for the possible purchase of Merck’s generics business. ...
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While the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continues to pay fees to Genentech to use the disputed technology to develop the drug Synagis, the U.S. Patent and Trademark Office may have something to add, too. ...
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BEDFORD, Ohio, February 22, 2007 /PRNewswire/ -- Bedford Laboratories(TM), a division of Ben Venue Laboratories Inc., announced FDA approval to begin shipping Methylprednisolone Sodium Succinate for Injection, USP. ...
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JERUSALEM--(BUSINESS WIRE)--Feb 22, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Rabeprazole Sodium Delayed-Release Tablets, 20 mg. ...
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Gurgaon, India, February 22, 2007 - In line with Ranbaxy’s plan to transform Terapia Ranbaxy into a strategic regional hub for its operations in Europe, the largest generics pharmaceutical company in Romania, has received the Manufacturing and Import Authorization according to the European Union (EU) norms and standards. ...
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The new Thai government has been experimenting with the compulsory licensing provisions of Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). To date, Thailand has unilaterally declared compulsory licenses for three patented drugs: (i) Stocrin, a first-line anti-retroviral used in treating HIV/AIDS; (ii) Kaletra, a second-line anti-retroviral also used to treat HIV/AIDS; and (iii) Plavix, a platelet anti-aggregant that reduces the risk of clot formation....
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NEW YORK, Feb. 23 (HSMN NewsFeed) -- Pfizer Inc said today that a Danish court has granted a preliminary injunction against Nomeco A/S -- the largest pharmaceutical wholesaler in Denmark -- that prohibits the sale of a generic version of Lipitor by generics manufacturer Ranbaxy. The injunction, issued by the Bailiff's Court of the Copenhagen City Court in Denmark and subject to possible appeal by Nomeco, requires Ranbaxy's generic atorvastatin product to be withdrawn from the Danish market pending the outcome of a patent infringement trial that has not yet been scheduled....
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We reported last month on a new declaratory judgment action that Apotex filed against GlaxoSmithKline in the Eastern District of Virginia. In its complaint, Apotex alleged that Glaxo's listing of a patent on Zantac Syrup in the Orange Book gave rise to a justiciable controversy sufficient to support declaratory judgment jurisdiction. The Federal Circuit has rejected similar claims before, most notably in Teva v. Pfizer. However, Apotex may have filed its new complaint hoping that the Supreme Court's recent decision in MedImmune v. Genentech would force a different outcome this time around....
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PITTSBURGH, Feb. 26 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets USP, 4mg and 8mg strengths....
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb. 26, 2007--Taro Pharmaceutical Industries Ltd. reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application for Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL ("ranitidine syrup")....
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Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”), a US subsidiary of Boehringer Ingelheim of Germany, have jointly filed a patent infringement lawsuit in the United States against Ranbaxy regarding its submission of an abbreviated new drug application (ANDA) for a generic version of Astellas’ product, sold under the trademark Flomax® (generic name: tamsulosin HCl; brand name in Japan: Harnal®) , which is used for the treatment of benign prostatic hyperplasia. The patent infringement action was filed at the US Federal District Court in New Jersey on May 13, 2005 requesting, among others, an order that date of approval of Ranbaxy’s ANDA be not earlier than the expiration on October 27, 2009 of Astellas’ US Patent No. 4,703,063 on tamsulosin HCl, or any later date of exclusivity Astellas and BIPI are or become entitled....
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PITTSBURGH, Feb. 27 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the district court for the Western District of Pennsylvania has ruled in favor of Pfizer in the amlodipine litigation. Mylan disagrees with the court's decision and plans to immediately appeal the ruling....
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There is more backlash by generic drug companies against the user fees for generic drug reviews proposed in the 2008 budget. The budget proposal would increase funds for FDA by $100 million, including a large increase in user fees for brand-name pharmaceutical companies and the first fees for generic pharmaceutical companies. The $2.1 billion FDA budget includes almost $444 million in user fees from industries regulated by the agency, with $15.7 million in fees from generic pharmaceutical companies....
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TOKYO, Feb. 27, 2007-Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo. President: Osamu Nagayama] (hereafter, Chugai) announced today that the Intellectual Property High Court granted judgments in favor of Chugai in a patent infringement suit and a revocation suit against a trial decision by the Japanese Patent Office, both filed by Ajinomoto Co., Inc....
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PITTSBURGH, February 28, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has launched Quinapril Tablets USP, 5mg, 10mg, 20mg and 40mg strengths, and Quinapril Hydrochloride (HCl) and Hydrochlorothiazide (HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg strengths. ...
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