Generics Industry News Search
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April 2006 News Archive |
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Jerusalem, Israel, April 2, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's ANDA for Deferoxamine Mesylate for Injection USP, 500 mg/vial and 2 g/vial. Shipment of this product will begin immediately....
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Aurobindo Pharma Limited is pleased to announce that it has received approval for Cefuroxime Axetil Tablets USP, 125 mg (base), 250 mg (base), 500 mg (base) from US FDA.
With this Oral Cephalosporin approval, Aurobindo’s product basket for the US market has increased to 13 (Final approvals). Apart from this, the Company has 10 Tentative Approvals for the US market....
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PALO ALTO, Calif., Apr 03, 2006 (BUSINESS WIRE) -- Connetics Corporation, a specialty pharmaceutical company that develops and commercializes dermatology products, today announced the filing of a Citizen Petition with the U.S. Food and Drug Administration (FDA) to request that any generic products that reference Soriatane(R) (acitretin) meet several criteria in addition to rigorous bioequivalency testing prior to approval....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--April 3, 2006--Akorn-Strides, LLC, a joint venture company formed between Akorn, Inc. and Strides Arcolab Limited, today announced that it has submitted its first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs. The proposed drug product is a parenteral injectable supporting the antiemetic market, which currently has annual sales of approximately $600 million. Patent protection for the reference-listed drug expires in September 2008....
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The FDA has granted six months of pediatric exclusivity for Cephalon's narcolepsy drug Provigil, a move that could delay generic competition on the drug until 2012, the company said.
The patent extension covers Provigil (modafinil) tablets through April 6, 2015. But under previous settlement agreements, four generic drugmakers are poised to launch the product in April 2012, the company added. The generic firms could have launched the generic version in October 2011 if Cephalon had not received pediatric exclusivity....
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Alcon, Inc. today announced it has filed a U.S. patent infringement complaint in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. The lawsuit is in response to Teva's submission of an Abbreviated New DrugApplication (ANDA) to the U.S. Food and Drug Administration (FDA) requesting approval to manufacture and sell a generic version of Alcon's VIGAMOX(R) (moxifloxacin HCI ophthalmic solution) prior to the expiration of the three existing U.S. patents covering this product....
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The Serious Fraud Office investigation into price fixing and market sharing by suppliers of generic drugs, specifically, warfarin and penicillin based antibiotics (amoxicillin, ampicillin, flucloxacillin, phenoxymethylpenicillin) has led to criminal proceedings being brought....
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HAYWARD, Calif.--(BUSINESS WIRE)--April 5, 2006--IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of SALAGEN(R) (Pilocarpine Hydrochlorine) 5 and 7.5 mg Tablets....
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Hospitals in the Premier Inc. healthcare alliance will save approximately $3 million through an innovative new generic injectable auto-substitution program....
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To strengthen its presence in the French Generics market, Zydus France SAS has entered into an agreement with Evolupharm which is the 2nd largest Groupment (a distribution channel with a large network of pharmacies) in France....
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06 Apr 2006 - Philadelphia, PA, US and Basingstoke, UK – April 06, 2006 -- Shire plc announces that it has received a Paragraph IV notice letter from Corepharma LLC advising of the filing of an Abbreviated New Drug Application (ANDA) for its carbamazepine extended release products, generic versions of Shire’s Carbatrol....
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HAYWARD, Calif.--(BUSINESS WIRE)--April 7, 2006--IMPAX Laboratories, Inc. today announced that Wyeth (NYSE: WYE), has filed a lawsuit against the Company in the United States District Court for the District of Delaware alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Effexor XR(R) 37.5mg, 75mg and 150mg capsules....
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Paris, France - April 10, 2006 - The sanofi-aventis Group announced today that the U.S. Court of Appeals for the Federal Circuit has ruled in its favour. This ruling reverses a prior decision of the U.S. District Court for the Central District of California in the Group's Lovenox patent infringement suit against Amphastar and Teva....
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SCHAUMBURG, Ill.--(BUSINESS WIRE)--April 11, 2006--American Pharmaceutical Partners, Inc. (APP), a leading specialty injectable pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mitoxantrone Injection, USP (Concentrate), the generic equivalent of Serono Labs' Novantrone(R)....
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BEDFORD, OH –April 11, 2006 – Bedford Laboratories™, a division of Ben Venue Laboratories Inc., has announced that it began shipping Mitoxantrone Injection USP on April 11, 2006. The product is AP rated and equivalent to Novantrone® by Serono Labs. Mitoxantrone is indicated as the initial chemotherapy for the treatment of pain related to advanced hormone-refractory prostate cancer....
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PARAMUS, N.J., April 11, 2006 /PRNewswire/ -- Mayne Pharma (USA) Inc. announces that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application for Mitoxantrone Injection, USP packaged in 20mg, 25mg and 30mg multiple-dose presentations.
Mitoxantrone is a generic equivalent to Serono's Novantrone(R) which generated annual sales of approximately $75 million in 2005....
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JERUSALEM--(BUSINESS WIRE)--Apr 12, 2006 - Teva Pharmaceutical Industries Ltd. announced today that further to its press release dated March 16, 2006, the U.S. Food and Drug Administration has denied Apotex's request for an agency determination that 180-day exclusivity for pravastatin 10, 20, and 40 mg has been triggered and run....
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PITTSBURGH, April 12 /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 (ANDA) for Fexofenadine Hydrochloride Tablets, 30mg, 60mg and 180mg....
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Hyderabad, India, April 13, 2006: Dr. Reddy's Laboratories announced that the U. S. Food and Drug Administration has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg. The Company will commence the commercial marketing of this product immediately....
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CORONA, Calif., April 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced it has completed its acquisition of Sekhsaria Chemicals Ltd. of Mumbai, India....
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PITTSBURGH, April 18 /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 (ANDA) for Finasteride Tablets USP, 5mg. Finasteride Tablets are the AB-rated generic equivalent of Merck's Proscar® Tablets, 5 mg, which had annual U.S. sales of approximately $390 million as of December 31, 2005, according to IMS Health....
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HOLZKIRCHEN, Germany, April 18, 2006 – Sandoz announced today that the European Commission has granted marketing authorization for the company’s recombinant human growth hormone Omnitrope®....
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Court Grants Stay of FDA Approval until after Close of Business Friday
JERUSALEM--(BUSINESS WIRE)--April 19, 2006--Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Columbia has denied Apotex's motion for a temporary restraining order and preliminary injunction relating to Apotex's challenge to Teva's 180 days of marketing exclusivity for the first generic version of Bristol-Myers Squibb's Pravachol(R) (pravastatin sodium) Tablets in the United States....
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A federal judge has ordered the U.S. Food and Drug Administration to decide after a long delay whether Novartis AG can market a version of human growth hormone as a bioequivalent to the one already sold by Pfizer Inc....
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Sydney, April 20th, 2006: GenericsWeb has brought together the generic pharmaceutical industry’s most highly reputable publishers - including Arrowhead, Urch, Datamonitor and Espicom - to create an industry dedicated business intelligence centre. Available reports include company, country and industry analysis that can be purchased online via credit card....
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20 Apr 2006 - Philadelphia, PA, US and Basingstoke, UK – April 20, 2006 -- Shire plc announces that on April 20, 2006 it received correspondence from the United States Food and Drug Administration (“FDA�) informing Shire that the FDA has not yet resolved the issues raised in Shire’s pending ADDERALL XR Citizen Petition....
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The Board of Actavis Group today announces an improved preliminary proposal to acquire all the outstanding PLIVA shares on the Zagreb Stock Exchange and all the PLIVA GDRs on the London Stock Exchange.
Reykjavik, Iceland, 20 April 2006 - The Board of Actavis Group today announces an improved preliminary proposal to acquire all the outstanding PLIVA shares on the Zagreb Stock Exchange and all the PLIVA GDRs on the London Stock Exchange. The revised proposal is HRK630 in cash per share and values PLIVA at approximately US$1.85 billion....
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Jerusalem, Israel, April 20, 2006 - Teva Pharmaceutical Industries Ltd. announced today that further to its press release dated April 19, 2006, Teva filed a motion to reconsider the stay of approval of its Abbreviated New Drug Application (ANDA) to market its generic version of Bristol-Myers Squibb's Pravachol®(Pravastatin Sodium) Tablets, 10 mg, 20 mg and 40 mg, and the Court has granted that motion and vacated the stay of approval....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--April 21, 2006--Akorn, Inc. today announced that it has signed an API Supply and Margin Sharing Agreement with Natco Pharma Limited, located in Hyderabad, India, to commercialize two ANDA injectable drug products....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--April 21, 2006 - Akorn-Strides, LLC, a joint venture company formed between Akorn, Inc. and Strides Arcolab Limited, today announced that it has submitted its first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs for a lyophilized injectable drug. The proposed drug product is an antibiotic injectable used to treat or prevent infections, which currently has annual sales of over $80 million....
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Jerusalem, Israel, April 23, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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 Wyeth's Protonix® (Pantoprazole Sodium) Delayed Release (DR) Tablets, 20 mg and 40 mg....
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The Federal Trade Commission’s Bureau of Competition today issued a summary of agreements filed with the Commission in fiscal year 2005 (ending September 30, 2005) by generic and branded drug manufacturers. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires drug companies to file certain agreements with the FTC and the U.S. Department of Justice....
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HAWTHORNE, N.Y., Apr 24, 2006 (PRIMEZONE via COMTEX News Netwrk) -- Taro Pharmaceutical Industries Ltd. and its affiliates and subsidiaries reported today that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg (carvedilol tablets) and for Ondansetron Hydrochloride Tablets, equivalent to 4 mg, 8 mg and 24 mg ondansetron base respectively (ondansetron tablets)....
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PITTSBURGH, April 25 /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 Cilostazol Tablets, 50mg and 100 mg....
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Gurgaon, Haryana, India, April 25, 2006 - Ranbaxy Laboratories Limited (Ranbaxy) today said that a five-judge panel of the Supreme Patent and Trademark Board of Austria (OPM) has unanimously affirmed an earlier ruling of the Austrian Patent Office, invalidating claims 1-3 (all claims sought by Ranbaxy to be invalidated) of Pfizer's Austrian Patent AT 207896, covering Atorvastatin calcium (Lipitor®)....
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CORONA, Calif., April 25, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that under a distribution agreement with Bristol-Myers Squibb Company (NYSE: BMY), the Company has initiated shipments of pravastatin sodium tablets in the 10, 20 and 40 mg. strengths....
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WILMINGTON, Mass., April 25, 2006 - DUSA Pharmaceuticals, Inc. announced today it has filed a patent infringement suit in the United States District Court in Trenton, New Jersey alleging that a River’s Edge Pharmaceuticals’ LLP niacinimide product infringes US patent 6,979,468. In response to a motion put forward with the filing by DUSA the Court granted an expedited hearing date of May 5, 2006 in order to hear arguments on a motion for preliminary injunction to enjoin River’s Edge Pharmaceuticals LLP from selling its alternative product to DUSA’s product, Nicomide®....
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Appellate Court Denies Apotex Request for Injunctive Relief
Jerusalem, Israel, April 25, 2006 - Teva Pharmaceutical Industries Ltd. 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 Bristol-Myers Squibb's Pravachol® (Pravastatin Sodium) Tablets, 10 mg, 20 mg and 40 mg....
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USTR to Initiate Review of China’s Province Level IPR Enforcement Efforts
WASHINGTON – The Office of the U.S. Trade Representative today released its Special 301 annual report on the adequacy and effectiveness of intellectual property rights (IPR) protection provided by trading partners around the world. The report identifies governments who need to take stronger actions to combat piracy and counterfeiting, for example, by cracking down on illegal optical disc production and Internet piracy, or stepping up border enforcement against trade in fake goods. Concerns regarding China and Russia feature prominently throughout the report....
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