Generics Industry News Search
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September 2008 News Archive |
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APP Pharmaceuticals, Inc. and Fresenius SE have received confirmation that the U.S. Federal Trade Commission (FTC) has completed its review of the proposed acquisition of APP Pharmaceuticals by Fresenius Kabi, a business segment of Fresenius SE. The FTC granted early termination of the waiting period under the Hart-Scott-Rodino Act without conditions. The German antitrust authorities had already approved the acquisition....
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Pharmaceutical firm Strides Arcolab today said it has received US regulatory approval for its two new drugs used for normalising blood circulation....
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Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has reached an agreement with Purdue Pharma L.P. to end a patent infringement lawsuit between them. In connection with the agreement, Purdue has agreed to grant Mallinckrodt a royalty-bearing license to sell limited quantities of oxycodone hydrochloride extended-release tablets for a limited period of time ending in 2009. As a result, Mallinckrodt expects to begin selling oxycodone hydrochloride extended-release tablets before the end of September 2008....
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Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. announced today that, as expected, each party has received a request for additional information (commonly referred to as a "second request") from the U.S. Federal Trade Commission (FTC) in connection with Teva's pending acquisition of Barr....
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Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories)....
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Sandoz has received US Food and Drug Administration approval for its Omnitrope Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency. ...
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Sun Pharmaceutical Industries today announced its subsidiary, Alkaloida Chemical Company Exclusive Group (Alkaloida), has extended the expiration date of the tender offer for the purchase of all outstanding ordinary shares of Taro Pharmaceutical Industries (Taro). The offer will now expire on Friday, October 3, 2008, unless further extended or earlier terminated. The offer had previously been scheduled to expire on Wednesday, September 3, 2008.
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A federal district court judge has ruled that three antitrust cases against Barr Pharmaceuticals filed by direct purchasers cannot be decided on summary judgment. ...
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The FDA questioned a decision by Sandoz to continue the distribution of Toprol XL....
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Daiichi Sankyo's open offer to acquire an additional 20 per cent stake in Ranbaxy Laboratories ended today.
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Perrigo Company announced today that it has acquired the exclusive U.S. rights to sell and distribute Levocetirizine tablets, the generic version of UCB's Xyzal tablets, from Synthon Pharmaceuticals, Inc. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing....
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Following the completion of a comprehensive review of strategic alternatives for Dey, L.P., Mylan Inc.'s branded specialty pharmaceutical subsidiary, Mylan announced today that it will retain the Dey business....
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India's Aurobindo Pharma Ltd. said it has received tentative approval from the U.S. Food and Drugs Administration (FDA) to manufacture and market Abacavir Sulfate or Lamivudine tablets, used in the treatment of AIDS.
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U.S. health regulators have warned Forest Laboratories Inc for promoting its hypertension drug Bystolic to doctors without properly noting the medication's risk, according to a letter released on Monday....
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Salix Pharmaceuticals, Inc. has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of the patent protecting OSMOPREP...
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Vectura Group plc announces that Sandoz is the exclusive licensee in certain territories for Vectura's combination asthma/COPD products, VR315 and VR632....
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Merck had sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application with the FDA for a generic version of FOSAMAX....
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Over the past year, the Federal Circuit has addressed on many occasions the scope of the "case or controversy" requirement for a court to have jurisdiction under Article III of the Constitution. Several of these decisions have been directed to the proper jurisdictional scope of declaratory judgment actions filed in ANDA cases, where a generic drug company has filed its ANDA on a drug having at least one patent listed by the innovator in the FDA Orange Book....
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GenericsWeb is thrilled to announce that the Generic Pharmaceutical Patent Academy is travelling to India for two events.
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Research and Markets has announced the addition of the "The Top 10 Generic Pharmaceutical Companies: Positioning, Performance and SWOT Analyses" report to their offering. ...
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The Board of Directors of Alpharma Inc. today urged shareholders to take no action with respect to the announcement by King Pharmaceuticals, Inc. that it intends to commence a tender offer to acquire all of the outstanding shares of Alpharma. ...
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Sun Pharmaceutical Industries Ltd. Friday said it has received final approval from the U.S. Food and Drug Administration to make and sell generic Alendronate Sodium tablets.
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RxElit Inc., which develops and markets generic prescription drug products in specialty generic markets in the areas of anesthesia, sterile liquid dose drugs (which includes ophthalmic and sterile inhalation respiratory products and injectable drugs), and active pharmaceutical ingredients (API), today announced that it had received a letter from its supplier, Minrad International, Inc. ...
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Fougera, today announced the FDA has approved its Clotrimazole Cream USP 1%. The generic formulation compares to Taro’s Referenced Listed Drug and is available in three sizes: 15g tubes, 30g tubes and 45g tubes.
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Teva Pharmaceutical Industries Ltd. announced today that following a hearing on September 12, 2008, the U.S. Court of Appeals for the District of Columbia has vacated an April 2008 ruling, which granted Teva 180-day exclusivity for its Risperidone Tablets, AB-rated to Janssen's Risperdal Tablets. As a result of this decision, the U.S. Food and Drug Administration is no longer enjoined from approving subsequent Abbreviated New Drug Applications (ANDA)....
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Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg....
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The government closed U.S. borders Tuesday to more than 30 generic drugs - including popular antibiotics and cholesterol medicines - made by India's biggest pharmaceutical company, citing poor quality in two of its factories....
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg....
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Perrigo Company announced today that it has acquired JB Laboratories for approximately $44 million in cash. Based in Holland, Michigan, privately-held JB Laboratories is a contract manufacturer of OTC and nutrition products for leading healthcare suppliers in the U.S. The acquisition is expected to add more than $70 million of annual sales....
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Brazil's health minister says Latin America's biggest country will produce an inexpensive generic version of an AIDS drug made by Merck & Co....
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Ranbaxy Laboratories Ltd., today announced that they have retained the services of former New York City Mayor Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues related to the recent United States Food and Drug Administration letters and Import Advisory.
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In response to a U.S. Food and Drug Administration press release today announcing warning letters and Import Alert for Drugs issued to Ranbaxy Laboratories Ltd regarding drug products produced in two Ranbaxy plants in India, the company issued the following statement.
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The Perrigo Company announced today that the Hatch-Waxman litigation relating to Miconazole Nitrate Vaginal Cream and Suppository between Johnson & Johnson and Perrigo has been dismissed. Earlier this year, Perrigo had been sued by
Johnson & Johnson's McNeil unit for infringement of a patent related to Perrigo's filing of an ANDA for a generic to Monistat(R) -1 Combination Pack in the United States District Court for the District of New Jersey. Following FDA approval, Perrigo will begin marketing its product under store brand and value brand labels to its customers....
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A wave of consolidation that has reshaped the generic drug industry in recent years will continue, experts say, as companies like Teva Pharmaceutical Industries and Mylan Inc. compete for new business in emerging global markets....
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Generic drug giant Teva Pharmaceutical Industries Ltd is unlikely to buy Germany's Stada as it eyes potential targets in other countries such as Japan, the Israeli company's top North American executive said on Friday....
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Sanofi-Aventis and Zentiva N.V. ("Zentiva") today announced an agreement on the unanimous recommendation by Zentiva of an intended improved all-cash public offer of CZK 1,150 per share (the "Improved Offer") by Sanofi-Aventis' wholly-owned subsidiary Sanofi-Aventis Europe to acquire all issued ordinary shares (including shares held in the form of GDSs) in the share capital of Zentiva.
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The World Health Organisation on Monday warned customers not to buy drugs made by Swiss pharma giant Novartis's Sandoz generics unit in South Africa after an inspection revealed more than 40 faults....
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Teva Pharmaceutical Industries Ltd. announced today the introduction of Nicardipine Hydrochloride Injection, 2.5 mg/mL, which is AP-rated to EKR Therapeutics' hypertension treatment Cardene I.V. Teva's product is the first alternative to the brand product, which had annual sales of approximately $181 million in the United States for the twelve months ended June 30, 2008, according to IMS sales data....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Carbidopa and Levodopa Orally Disintegrating Tablets, 10 mg/100 mg, 25 mg/100 mg and 25 mg/250 mg....
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Apotex Inc, the largest Canadian-owned pharmaceutical company, is pleased to announce that Apo-TriAvir, a triple combination HIV/AIDS drug, approved under Canada's Access to Medicines Regime (CAMR), is ready to ship to Rwanda, the only country to make a request through a program tender process. The first shipment of seven million tablets, which will help save the lives of 21,000 people, is scheduled to leave from Toronto on September 24th, 2008. Apotex is doing this on a humanitarian, not-for-profit basis.
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for the Abbreviated New Drug Application to market generic Paraplatin, carboplatin injection.
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Teva Pharmaceutical Industries Ltd. and Kowa Company, Ltd. today announced that they have signed a definitive agreement to establish a leading generic pharmaceutical company in Japan.
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Domestic pharmaceutical major Cipla has launched a copycat version of Swiss drug-maker Roche's anti-infection drug, valganciclovir, in India, even as the drug enjoys patent protection in the country.
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AstraZeneca today announced that the US District Court for the District of New Jersey has denied Teva's Motion for Summary Judgment of no infringement in the PULMICORT RESPULES (budesonide inhalation suspension) patent litigation. ...
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Daiichi Sankyo Company, Limited has made the open offer for common shares in Ranbaxy Laboratories Limited, which had been conducted during the period from August 16, 2008 to September 4, 2008....
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The European Medicines Agency on Thursday recommended approval of a Slovenian drugmaker Krka's generic version of Aprovel, a blood pressure treatment made by Sanofi-Aventis. ...
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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Didanosine Delayed Release (Enteric-Coated) Capsules 125mg, 200mg, 250mg and 400mg.
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The Board of Directors of Alpharma Inc., a global specialty pharmaceutical company, today filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 and sent a letter to shareholders in which the Alpharma Board unanimously rejected King Pharmaceuticals, Inc.'s unsolicited tender offer to acquire all of the outstanding shares of Alpharma for $37.00 per share as financially inadequate and not in the best interests of shareholders....
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A recent case heard in the Federal Court of Australia illustrates the need for comprehensive, accurate and regularly updated patent information to ensure that the planned launch of a generic pharmaceutical product is not delayed.
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Elite Pharmaceuticals, Inc. in collaboration with ThePharmaNetwork, LLC., announced today the acceptance by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for a generic equivalent of a synthetic narcotic analgesic drug product. ...
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The Acino Group has won yet another favorable court ruling in the legal proceedings regarding clopidogrel.
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Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced today the U.S. Food and Drug Administration's approval of its 10 mg/mL strength of Ketamine Hydrochloride Injection, USP, the generic equivalent of JHP Pharmaceuticals' Ketalar.
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