Generics Industry News Search
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January 2007 News Archive |
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BALTIMORE, January 02, 2007 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets...
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PRINCETON, N.J., January 02, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Atenolol Tablets...
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PITTSBURGH, Jan. 3 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted the company approval to market its currently approved Levothyroxine Sodium Tablets, ...
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LOS ANGELES--(BUSINESS WIRE)--Jan 4, 2007 - Abraxis BioScience, Inc. (NASDAQ: ABBI), an integrated, global biopharmaceutical company, today announced that it has launched Ondansetron Injection, USP, the generic equivalent of GlaxoSmithKline's Zofran(R) Injection....
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Reliant Pharmaceuticals has filed a lawsuit in the U.S. District Court for the District of Delaware against Par Pharmaceutical for infringement of U.S. Pat. No. 5,681,588. The ‘588 patent, which expires in 2014, relates to Reliant’s Rythmol® SR (propafenone) product.
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PITTSBURGH and HYDERABAD, India, Jan. 8 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. and Matrix Laboratories Limited today announced that Mylan has completed its acquisition of approximately 51.5% of Matrix's outstanding shares for Rs. 306 per share in cash pursuant to a share purchase agreement (SPA) with certain selling shareholders....
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ARLINGTON, Va., January 09, 2007 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today said the U.S. Supreme Court's decision in MedImmune v. Genentech is a win for consumers, enabling affordable medicines to reach the market in a timely manner. ...
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jan 9, 2007 - Akorn, Inc. (AMEX: AKN) today announced that it has signed a Definitive Agreement with Azad Pharma, a privately-held pharmaceutical company located in Toffen, Switzerland, to develop and supply Latanoprost, Bimatoprost and Travoprost,...
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GAITHERSBURG, Md., January 10, 2007 /PRNewswire-FirstCall/ -- MedImmune, Inc. today announced that the U.S. District Court for the District of Maryland has rejected Sun Pharmaceutical Industries, Ltd.'s (Sun) motion to end the patent infringement action regarding Sun's proposed generic amifostine product. MedImmune Oncology, Inc. initially filed suit against Sun in August 2004....
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PHILADELPHIA--(BUSINESS WIRE)--Jan 11, 2007 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, announced today that it will shortly commence distributing Meloxicam, the generic equivalent of Boehringer Ingelheim's Mobic(R). Sales of Meloxicam, ...
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LONDON: Texas Pacific Group, Cinven and Permira Advisers may bid for the generic drug division of Merck KGaA, according to four people familiar with the discussions....
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CINCINNATI--(BUSINESS WIRE)--Jan 16, 2007 - Prasco Laboratories, a Cincinnati-based generic pharmaceutical company, announced today it has begun shipping Sodium Sulfacetamide Lotion 10%, the authorized generic of sanofi-aventis' Klaron(R)(1). ...
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Abbott Labs won a ruling preventing Andrx Pharmaceuticals from selling generic versions of the antibiotic Biaxin XL until a patent suit is resolved....
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CINCINNATI--(BUSINESS WIRE)--Prasco Laboratories, a Cincinnati-based generic pharmaceutical company, announced today it has begun shipping Sodium Sulfacetamide Lotion 10%, the authorized generic of sanofi-aventis’ Klaron®1. Sodium Sulfacetamide Lotion 10% is AB-rated to Klaron and is indicated in the topical control of acne vulgaris. ...
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The FDA has approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy....
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TORONTO, Jan. 15 /CNW/ - The Canadian Generic Pharmaceutical Association (CGPA) is pleased to announce the election of Allan Oberman, President and Chief Executive Officer of Novopharm, as Chair of CGPA.
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The Chennai-based drug maker, Orchid Chemicals (Q, N,C,F)* & Laboratories plans to acquire a European company, with the aim of becoming a USD 1 billion company by 2011, reports Economic Times. ...
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The district court granted a preliminary injunction to stop Andrx from selling extended release clarithomycin as a generic version of Biaxin XL. Andrx appealed....
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CHICAGO, January 17, 2007 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved six additional companies to begin selling generic versions of the cholesterol-lowering drug Zocor(R) (simvastatin), effective Dec. 27, 2006. Previously, only two generic simvastatins competed against Zocor; these drugs were approved in June 2006 and granted 180-day exclusivity, which ended on Dec. 23. ...
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WASHINGTON (Reuters) - Key senators from both political parties said on Wednesday they would back legislation that would stop drugmakers from striking deals to restrict the introduction of cheaper generic drugs....
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WOODCLIFF LAKE, N.J., Jan. 18 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL(R) (granisetron hydrochloride) Tablets, 1mg (base). ...
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LAKE FOREST, Ill., Jan. 18 /PRNewswire-FirstCall/ -- Hospira, Inc., a leading global hospital products company, and Mayne Pharma Limited, a leading Australia-based specialty injectable pharmaceuticals company, today announced that, subject to the divestiture of certain overlapping products, the U.S. Federal Trade Commission (FTC) has cleared the way for Hospira to proceed with its proposed acquisition of Mayne. ...
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On Wednesday, December 13, 2006, Celgene Corp. announced that it had received notification from Barr Laboratories, Inc. that Barr had filed an ANDA for generic thalidomide, 200 mg tablets, sold by Celgene under the brand name Thalomid. On December 26, 2006, Celgene announced that it had received notification of Barr's ANDA for the 50 and 100 mg strengths of Thalomid. The ANDAs contained paragraph IV certifications that any applicable Celgene patents are invalid, unenforceable, and/or not infringed....
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Aurobindo Pharma Limited is pleased to announce that the company has received one more approval from the US FDA for Amoxicillin tablets for oral suspension 200mg and 400mg....
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WOODCLIFF LAKE, N.J., January 19, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that it has launched a generic version of Bristol-Myers Squibb Company's METAGLIP(TM) (Glipizide and Metformin HCl) Tablets, ...
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DETROIT, Jan. 19 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. confirmed today that the U.S. Federal Court of Appeals for the Federal Circuit in Washington upheld the United States District Court for the Eastern District of Michigan ruling that Caraco does not infringe Ortho-McNeil Pharmaceutical, Inc.'s U.S. Patent No. 5,336,691. Caraco's Tramadol with Acetaminophen is the generic equivalent of Ortho McNeil's analgesic, Ultracet(R)....
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We previously reported on Apotex's lawsuit against the FDA concerning generic Zofran (ondansetron HCl) tablets. Apotex sought an injunction directing FDA to approve Apotex's ANDA for generic Zofran tablets when GlaxoSmithKline's pediatric exclusivity on Zofran expired on December 24, 2006. Although Dr. Reddy's was the first to file an ANDA for generic Zofran tablets, Apotex argued that a May 2005 district court dismissal of GSK's lawsuit against Apotex triggered Dr. Reddy's 180-day exclusivity period, which then ran to completion in December 2005.
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WOODCLIFF LAKE, N.J., January 23, 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 Azithromycin for Injection, 500 mg vial, the generic version of Pfizer Labs' ZITHROMAX(R) IV (azithromycin for injection). The Company intends to launch its product during the first quarter of 2007....
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JERUSALEM--(BUSINESS WIRE)--Jan 24, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has filed infringement complaints against a number of finished dose companies which manufacture sertraline hydrochloride, AB rated to Zoloft(R), and their active pharmaceutical ingredient suppliers....
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On Friday, the U.S. Court of Appeals for the Federal Circuit denied a petition to rehear by Apotex asking the Federal Circuit to reconsider a ruling that Apotex is barred from selling its generic version of the anticlotting drug Plavix while Apotex continues its five-year patent lawsuit with Sanofi-Aventis....
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This bench trial addresses patent validity and enforceability issues different from those considered in the jury trial. Lilly contends that the asserted claims of US 6,410,516 are invalid for including non-statutory subject matter, for being obtained through inequitable conduct, and are unenforceable due to prosecution laches....
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Generic drug makers typically set their litigation sights on brand-name drug companies. Their goal is to invalidate the brand companies' patents and earn the right to market their generic drugs before the patents expire. Increasingly, however, generics are suing each other to protect or gain market share....
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PRINCETON, N.J., Jan. 26 /CNW/ -- Ranbaxy Laboratories Limited announced that the Federal Court of Canada today handed down a favorable decision in the company's case against Pfizer by finding invalid Pfizer's Canadian atorvastatin patent CA 2,021,546. Atorvastatin is a cholesterol- lowering drug which is marketed by Pfizer as Lipitor(R)....
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Woodcliff Lake, NJ, Jan. 29, 2007 — Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced it has received final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for propranolol hydrochloride (HCl) extended release (ER) capsules in 60-, 80-, 120- and 160 mg dosage strengths....
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Lipitor (atorvastatin calcium), indicated for the reduction of cholesterol, is the world's best-selling pharmaceutical. Ranbaxy has applied to market a generic version of Lipitor and has challenged Pfizer's patents on Lipitor in many countries around the world--usually without success. For instance, in August 2006 the Federal Circuit upheld the validity of Pfizer's U.S. Patent No. 4,681,893. (In the same decision the Federal Circuit invalidated Pfizer's U.S. Patent No. 5,273,995...
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FAJARDO, Puerto Rico and CORONA, Calif., January 29, 2007 /PRNewswire/ -- Warner Chilcott Company, Inc. and Watson Pharmaceuticals, Inc. announced today that under a supply agreement between Warner Chilcott and Watson Pharma, Inc., Watson has launched Zenchent(TM) (norethindrone and ethinyl estradiol tablets USP), the generic version of Warner Chilcott's oral contraceptive Ovcon 35(R). ...
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HYDERABAD, India | Jan 29, 2007 | Aurobindo Pharma is pleased to announce that the company has received one more approval from USFDA for Cefadroxil capsules 500mg. Cefadroxil is a first generation Cephalosporin antibiotic. It is used in a wide variety of bacterial infections (respiratory, skin & soft tissue, and Urinary tract infections)....
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MUMBAI, India, January 30, 2007--Strides Arcolab and Invent Farma Group, which includes Laboratorios Lesvi and Inke, a leading Spanish company, announced to set up a JVC to develop a range of products mainly focused for hospitals in the Spain and Portugal region. ...
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PITTSBURGH, January 30, 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 Albuterol Sulfate Extended-release (ER) Tablets, 4mg (base) and 8mg (base). ...
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JERUSALEM--(BUSINESS WIRE)--Jan 30, 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) to market its generic version of Novartis' Focalin(TM) (Dexmethylphenidate Hydrochloride) Tablets, 2.5 mg, 5 mg, and 10 mg....
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WOODCLIFF LAKE, N.J., January 30, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that it has launched a generic version of Merck & Co. Inc.'s PROSCAR(R) (Finasteride) Tablets, 5 mg in the U.S. under an agreement with Gedeon Richter . The Company launched the product following final approval from the U.S. Food and Drug Administration (FDA) for Gedeon Richter's Abbreviated New Drug Application (ANDA). ...
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PITTSBURGH, January 31, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval for its Abbreviated New Drug Application (ANDA) for Valacyclovir Hydrochloride Tablets, 500mg (base) and 1000mg (base). ...
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PITTSBURGH, January 31, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Technologies' Supplemental Abbreviated New Drug Application for its 12 mcg/hr Fentanyl Transdermal System. This product is shipping immediately....
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PRINCETON, N.J., January 31, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg (base) / 5 mL....
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