Generics Industry News Search
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July 2006 News Archive |
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The Indianapolis Star reported that Eli Lilly and Co. sued Teva in federal court in Indianapolis to try to prevent it from selling a generic version of the osteoporosis drug Evista....
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Strides Arcolab Limited today announced that the World Health Organization has included in its list of pre-qualified suppliers generic fixed dose combination of Anti-HIV drug – Lamivudine / Zidovidine developed by Strides.
Prior to this approval, Strides has 4 HIV drugs in the WHO pre-qualified list....
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On Friday, June 30, 2006, the U.S. District Court for the Northern District of California issued a decision in the suit brought by Tercica Inc and Genentech, Inc against Insmed, Inc. and two of its subsidiaries alleging infringement of three U.S. patents. The Court ruled on issues of claim construction and on motions by both sides for partial summary judgment....
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The Court of Appeals for the Fourth Circuit today affirmed a district court decision dismissing a lawsuit brought by Mylan Laboratories against the FDA, in which Mylan asserted that the FDA did not have the authority to approve an authorized generic of Proctor & Gamble's Macrobid (nitrofurantoin)....
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PARIS, July 5, 2006 - Ethypharm announced it launched its micronized fenofibrate 160 mg tablet with major French generic companies on the French market, last may. Ethypharm's product is the first generic Fenofibrate 160 to be launched on the French market....
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Reykjavik, Iceland, 5 July 2006 - Actavis Group today announces the launch of five new products in the United States, all of which will be marketed under the Group's own label....
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Generic drug-maker Apotex filed a complaint on June 26, 2006 in the U.S. District Court for the Eastern District of Pennsylvania accusing Cephalon Inc. and its licensees, generic drug-makers Barr Laboratories, Mylan Laboratories, Teva Pharmaceuticals, and Ranbaxy Laboratories, with monopolization under the Clayton Act and the Sherman Act, and intent to monopolize under the Sherman Act....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jul 6, 2006 - Akorn, Inc. today announced that it has received an ANDA approval for Amiodarone Hydrochloride Injection. The product will be manufactured in the Decatur, IL Facility, and is the sixth product approval received by Akorn this year....
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WOODCLIFF LAKE, N.J., July 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Janssen Pharmaceutica N.V., Janssen, L.P., Ortho-McNeil Neurologics, Inc. and Synaptech, Inc. (Plaintiff) filed suit against it and its subsidiary, Barr Laboratories, Inc., relating to the patent protecting Razadyne(R) ER (Galantamine Hydrobromide Extended-Release Capsules), 8 mg, 16 mg and 24 mg....
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PLIVA d.d. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Applications (“ANDAs”) for Azithromycin for Oral Suspension and Warfarin Sodium Tablets and has granted a tentative approval for its ANDA for Ondansetron Hydrochloride Tablets....
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Deadline Extended to November 13, 2006 to Allow for Further FTC Review
CORONA, Calif. & FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--July 10, 2006--Watson Pharmaceuticals, Inc. and Andrx Corporation today announced that they have entered into an amendment to their March 12, 2006 definitive merger agreement pursuant to which, subject to certain conditions, the deadline to close the transaction has been extended from September 12, 2006 until November 13, 2006....
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State of play and Pfizer’s recent win on appeal in the UK
Take home
Despite litigation in at least ten jurisdictions across the world, Ranbaxy has so far been unable to obtain launch before patent expiry (~2011). (Further analysis below.)...
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Aurobindo Pharma is proud to announce that the US FDA has granted tentative approval for Didanosine tablets (Chewable) of strengths 100mg, 150mg & 200mg. This is the first generic version approval of Didanosine chewable in the world given by US FDA....
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Chennai, India - July 12, 2006 - The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd today announced that it has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) of Cephalexin oral suspension....
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Jerusalem, Israel, July 12, 2006 - Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. today announced that they have mutually agreed to end their May 2003 alliance to co-promote Teva's AZILECT® (rasagiline tablets) for Parkinson's disease in the United States....
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DETROIT, July 12 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., 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 Glipizide tablets....
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JERUSALEM--(BUSINESS WIRE)--Jul 12, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' hypertension treatment Lotrel (Amlodipine Besylate and Benazepril HCl) Capsules, 2.5 mg base/10 mg, 5 mg base/10 mg, 5 mg base/20 mg, and 10 mg base/20 mg....
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Fort Lee, New Jersey, July 13, 2006 - DAVA Pharmaceuticals, Inc. announced today that it has entered into an agreement with STADA Arzneimittel AG for the purchase of its wholly-owned subsidiary, STADA, Inc. STADA, Inc. owns and operates STADA AG's U.S. generic pharmaceutical business....
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PITTSBURGH, July 13 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg (base)/20 mg....
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BOTHELL, Wash., July 13 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. announced today that written notification from the FDA was received on July 10, 2006 stating that Nastech's abbreviated new drug application (ANDA) for intranasal calcitonin-salmon is not approvable at this time. In a subsequent conference call on July 11, 2006, Nastech reviewed the status of the ANDA with the FDA....
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STADA Arzneimittel AG is to completely take over the Serbian Pharmaceuticals Group Hemofarm a.d., Vrsac, Serbia. To this end, STADA will in Serbia, today, on July 14, 2006, submit a public takeover offer to the Commission for Securities of the Republic of Serbia for all 3.3 million shares of the company which has been listed on the stock exchange in Belgrade since 2002. Hemofarm’s management has welcomed STADA’s takeover offer....
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The U.S. District Court for the District of Delaware released its opinion last Thursday in the Lexapro patent infringement case, finding in favor of Forest Labs. Forest, the maker of Lexapro, sued IVAX, a division of Teva, for patent infringement based on IVAX's ANDA to market generic versions of Lexapro. Forest took in over $2 billion on Lexapro sales in the U.S. last year....
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NEW YORK, NY -- (MARKET WIRE) -- July 17, 2006 -- China Aoxing Pharmaceutical Corp. announced that on June 8, 2006 its subsidiary, Hebei Aoxing Pharmaceutical Group, received new product approvals from the State Food and Drug Administration, P.R. China. Both the Naloxone Hydrochloride itself and the Naloxone Hydrochloride injections in various specifications, have met applicable regulations detailed in the Drug Administration Law of the People's Republic of China and obtained new drug registration approvals....
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Mumbai, July 17, 2006: Glenmark Pharmaceutical [UK] Ltd, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. and Generics [UK] Limited, on behalf of the Merck Generics Group, a subsidiary of Merck KGaA of Darmstadt, Germany, have entered into an agreement for the joint development, filing and marketing of 8 generic dermatological products for Europe, which have a current annual sales value of around USD 225 Mn in the region....
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NEW YORK – July 17, 2006 – Inyx, Inc., a specialty pharmaceutical company focused on niche drug delivery technologies and products, announced today that its wholly owned U.K. subsidiary, Ashton Pharmaceuticals Ltd., has been selected by a vertically integrated, emerging global pharmaceutical company based in India to manufacture a range of generic drugs for the United Kingdom and other European countries....
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Gurgaon, Haryana, India - July 17, 2006 - Ranbaxy Laboratories Limited, today announced that Nihon Pharmaceutical Industry Ltd., a Joint Venture between RLL and Nippon Chemiphar Limited, has successfully launched Clarithromycin 50mg, 200mg tablets (Innovator- Taisho/Dinabbot; Brand name Clarith/Klaricid) and Terbinafine 125mg tablets (Innovator- Novartis; Brand name Lamisil)....
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Gurgaon (Haryana), India, July 18th, 2006 - Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, and among the top ten generic pharmaceutical companies in the world, announced today that the Company has acquired the Mundogen generic business of GlaxoSmithKline (GSK), in Spain, through Ranbaxy’s Spanish subsidiary, Laboratorios Ranbaxy S.L....
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HAWTHORNE, N.Y., Jul 18, 2006 (PRIMEZONE via COMTEX News Network) -- Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Metronidazole Topical Gel USP, 0.75% (metronidazole gel)....
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First Indian Company to market a licensed generic in Canada
Gurgaon, Haryana, India – July 19, 2006 - Ranbaxy Laboratories Limited (RLL), India, today announced that the Company’s wholly owned subsidiary, Ranbaxy Pharmaceuticals Canada Inc. (RPCI) and Janssen-Ortho Inc. (JOI), have entered into a licensing and supply agreement for a generic version of Risperidone compressed tablets, sold under Ranbaxy's label, Ran™ Risperidone. Ranbaxy is the first Indian company to market a licensed generic product in Canada....
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DETROIT, July 19 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., 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 Meloxicam Tablets....
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BALTIMORE, July 19, 2006 /PRNewswire/ -- Lupin Ltd. announced today that the United States District Court for the Eastern District of Virginia has issued an opinion following the completion of a trial on sanofi-aventis' U.S. Patent No. 5,061,722 relating to Altace(R) and found the patent to be valid....
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Applauds Bill for Preserving Hatch-Waxman Patent Challenge Incentive
ARLINGTON, Va., July 20 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today praised legislation introduced by Senator John D. Rockefeller IV (D-WV), Senator Charles E. Schumer (D-NY) and Senator Patrick Leahy (D-VT) that would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generics during the 180-day exclusivity period of generic pharmaceutical patent challengers....
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JERUSALEM, Israel--(BUSINESS WIRE)--Jul 20, 2006 - 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 (ANDA) for Meloxicam Tablets, 7.5 mg and 15 mg. Shipment of this product will begin immediately....
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There Have Been, Continue to Be, Competitive Problems in Pharmaceutical Markets
WASHINGTON, July 20, 2006--Testifying today on behalf of the Federal Trade Commission before the U.S. Senate’s Special Committee on Aging, Commissioner Jon Leibowitz described the FTC’s work in the area of branded and generic pharmaceutical competition and discussed barriers that can lead to the delay of generic entry into the U.S. marketplace....
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From Duncan Bucknell - www.DuncanBucknell.com
Grant v Commissioner of Patents [2006] FCAFC 120...
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Mylan Testifies Before Congress on Heels of Introduction of New Authorized Generic Legislation
WASHINGTON, July 20 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. testified before the U.S. Senate Special Committee on Aging today concerning potential solutions for authorized generics, citizen petitions and other issues that delay generic pharmaceutical approvals and put at risk billions of dollars of consumer healthcare savings....
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Mumbai, July 20, 2006: Glenmark Pharmaceuticals Limited received US FDA approval to market Meloxicam oral tablets 7.5 mg and 15 mg, a generic version of Boehringer Ingelheim’s brand Mobic. The drug belongs to a category of Non-steroidal Anti-Inflammatory Drugs [NSAID] and is prescribed for the indication of Osteoarthritis with annual sales of about USD 936 million....
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PITTSBURGH, July 20 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Meloxicam Tablets, 7.5 mg and 15 mg....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jul 24, 2006 - Akorn, Inc. today announced that it has received an ANDA approval for Diltiazem Hydrochloride Injection, 5mg/mL in 25 mL vials. The product will be manufactured in the Decatur, IL facility, and is the seventh product approval received by Akorn this year....
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PITTSBURGH, July 25 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted final approval for Mylan Technologies Inc.'s (MTI) supplemental Abbreviated New Drug Application for Estradiol Transdermal Systems, 0.0375 mg/day and 0.06 mg/day. These products will be added to the four additional strengths of Estradiol Transdermal Systems that Mylan is already marketing....
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Focus on developing four complex generic and follow-on biotechnology drugs, capitalize on Momenta’s complex product characterization technology
Commitment of up to $263 million for four major products...
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FAIRFIELD, N.J.--(BUSINESS WIRE)--Jul 25, 2006 - Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. have jointly filed in the U.S. District Court for the Southern District of New York a patent infringement lawsuit against Apotex Inc., a Canadian generic pharmaceutical manufacturer, and Apotex Corp., its U.S. subsidiary....
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CRANFORD, N.J., July 26, 2006 /PRNewswire-FirstCall/ -- Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group, received approval from the U.S. Food & Drug Administration to market Meloxicam Tablets. Shipment of the product will begin immediately....
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ROCKVILLE, Md., July 26, 2006--The Food and Drug Administration granted tentative approval on July 26, 2006 for lamivudine/zidovudine tablets co-packaged with abacavir sulfate tablets for treatment of HIV, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India....
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STAINES, England, July 27 /PRNewswire/ -- Astellas Pharma Europe, Ltd., the European affiliate of Astellas Pharma Inc. (Astellas), today announced that Astellas instituted legal proceedings at the Juzgados de los Mercantil of Madrid against the generic pharmaceutical companies Ratiopharm España, S.A., Laboratorio Stada, S.L., Laboratorios Edigen, S.A., Merck Genéricos, S.L., Bexal Famacéutica, S.A., Sandoz Farmacéutica, S.A., and Teva Genéricos España, S.L., who have launched or are expected to launch modified-release hard capsules with the active ingredient tamsulosin hydrochloride on the Spanish market....
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Could Decrease Generic Drug Access, Advocates, Officials Say
Kenya's Parliament on Thursday is scheduled to debate proposed amendments to its patent law, some of which are opposed by some HIV/AIDS advocates because they say the amendments could decrease access to antiretroviral drugs, Reuters South Africa reports (Kanina, Reuters South Africa, 7/26)....
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FAIRFIELD, N.J., July 27 /PRNewswire-FirstCall/ -- BRADLEY PHARMACEUTICALS, INC. announced today that the Company's A. Aarons subsidiary has launched authorized generic versions of therapies provided by Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals. As previously announced on January 4, 2006, A. Aarons was established to market authorized generic versions of therapies provided by Bradley's operating units....
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PLIVA d.d. announces that it has finalised an agreement with Mayne Pharma, a leading oncology-focused specialty pharmaceuticals company, for the continued development of biosimilar granulocyte-colony stimulating factor (G-CSF) for the European, South East Asian, Middle Eastern and Asia Pacific markets....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jul 28, 2006 - Akorn, Inc. today announced that it has received a second ANDA approval for Diltiazem Hydrochloride Injection, 5mg/mL in 5 and 10 mL vials. The product will be manufactured in the Decatur, IL facility, and is the eighth product approval received by Akorn this year....
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Paris, France and New York (July 28, 2006) -- Sanofi-aventis and Bristol-Myers Squibb today announced that their agreement, as amended, with Apotex Inc. and Apotex Corp., to settle the patent infringement lawsuit pending between the parties in the U.S. District Court for the Southern District of New York has failed to receive required antitrust clearance from the state attorneys general....
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PHOENIX--(BUSINESS WIRE)--Jul 31, 2006 - Synovics Pharmaceuticals, Inc., a specialty pharmaceutical company with proprietary technologies for the development of oral controlled-release (OCR) generic and branded oral drugs, today announced the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for a generic version of metformin Extended Release (XR) Tablets 500mg. Bristol-Myers Squibb Company markets the therapeutically equivalent listed drug, Glucophage(R) XR Extended-Release Tablets 500mg....
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FAJARDO, Puerto Rico, July 31 /PRNewswire/ -- Warner Chilcott Company, Inc. announced today that it has filed suit against Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc. in the United States District Court for the District of New Jersey alleging infringement of Warner Chilcott's U.S. patent that protects Loestrin® 24 Fe....
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Toronto –Orbus Pharma Inc. today announced that they have entered into a development, manufacture and supply agreement with ratiopharm inc., of Mississauga, Ontario, to develop and supply a generic product used in the treatment of depression for the Canadian market....
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