Generics Industry News Search
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February 2011 News Archive |
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Valeant Pharmaceuticals International, Inc. and PharmaSwiss S.A. announced today that they have signed a binding agreement for Valeant to acquire PharmaSwiss, a privately-owned branded generics and over-the-counter (OTC) pharmaceutical company based in Zug, Switzerland for euro 350 million....
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The Washington Legal Foundation this week urged the U.S. District Court for the District of Columbia not to dismiss a challenge to an FDA rule that makes it easier for generic drug manufacturers to demonstrate that their products are bioequivalent to a brand-name drug already on the market...
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Sanofi-Aventis SA failed to block two generic drug manufacturers from selling a copy of the cancer drug Taxotere in Australia, with a federal court judge refusing to bar the sale of the generics...
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Teva Pharmaceutical Industries may have had a golden year in 2010, with the company having posted unprecedented growth. However, 2011 looks set to be more challenging. Aggressive filings and growth in key markets such as Latin America should help Teva to avoid declining growth rates such as those seen by key competitors like Sandoz in 2010...
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Last week, Senator Herb Kohl introduced the Preserve Access to Affordable Generics Act in the Senate. The bill, which is co-sponsored by Senators Sherrod Brown, Susan Collins, Richard Durbin, Al Franken, Chuck Grassley, Amy Klobuchar, and Bernard Sanders, is designed to prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market...
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It has been a long road for the NDP bill that aims to fix problems with a Canadian initiative to send generic copies of brand-name drugs to the world's poorest countries...
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Low doses of an inexpensive, FDA-approved hypertension medication may improve the results of nanotherapeutic approaches to cancer treatment...
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With the big pharma reporting season in full swing more than one chief executive has been heard to warn of tough times ahead. The cautious tone is justified - the sector is facing a perfect storm of pricing pressure and a swathe of blockbuster patent expiries...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application to market a generic version of Razadyne ER, galantamine hydrobromide extended-release capsules...
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Generic pharmaceuticals maker Natco Pharma is gearing up to take on German healthcare giant Bayer AG...
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration approval of Topotecan Injection, the first solution formulation of the oncology drug approved in the United States...
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San Diego-based Somaxon Pharmaceuticals has sued a competitor, which is looking to market a generic version of its Silenor insomnia drug...
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AVEO Pharmaceuticals, Inc. today announced that the United States Adopted Names Council, in consultation with the World Health Organization International Nonproprietary Names Expert Committee, has approved the use of the nonproprietary generic name "ficlatuzumab" for AV-299, a potent, functional anti-HGF/c-MET antibody internally discovered at AVEO...
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Nycomed today announced that it is expanding its presence in Latin America through the acquisition of Laboratorios Farmacol S.A., a Colombia based pharmaceutical company, which has a strong presence in the areas of gastroenterology, respiratory and gynaecology...
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Elite Pharmaceuticals, Inc. announced today the approval of an Abbreviated New Drug Application for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration...
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In Merck & Co. Inc. v. Apotex Inc., the Federal Court found Apotex to have infringed Merck's Canadian Patent No. 1,161,380, a product-by-process patent for the medicine lovastatin...
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US Senators and state Attorneys General have launched new bids to ban "pay-for-delay" deals between brand-name and generic drugmakers...
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Pfizer Japan Inc. and Takeda Pharmaceutical Company Limited announced today an agreement to extend the period for co-promotion in Japan for the rheumatoid arthritis (RA) drug Enbrel (generic name: etanercept)...
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In Wyeth v. Levine, 129 S.Ct. 1187 (2009), the U.S. Supreme Court held that failure-to-warn claims against brand-name drug manufacturers were not automatically preempted under the federal Food, Drug and Cosmetic Act simply by virtue of the fact that the Food and Drug Administration had approved the drug's labeling...
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Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today the U.S. Food and Drug Administration has approved Hologic's pharmaceutical named Makena (hydroxyprogesterone caproate injection), formerly known as Gestiva...
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According to our latest report entitled "Brazil Generics Market Forecast to 2012", factors like, increasing prevalence of diseases and expanding proportion of old people in the total population have significantly contributed to the development of generic drugs market in Brazil...
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Taj Pharmaceuticals Ltd. and ASTRAZENECA Pharmaceuticals, Inc. announced today the commercial launch of Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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The USA's Patent Reform Bill, as announced last week, was broadly welcomed by the research-based pharmaceutical and biotechnology industries, but it received a very different response from makers of generic medicines...
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The Abbreviated New Drug Application backlog in the US Food and Drug Administration's Office of Generic Drugs continued to grow unabated in 2010...
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Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Natco Pharma Limited submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Tamiflu (oseltamivir phosphate) 75 mg capsules...
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Santhera Pharmaceuticals announced today, that the United States Patent and Trademark Office and the Canadian Intellectual Property Office granted patent protection for the use of omigapil for the treatment of Congenital Muscular Dystrophy until 2027 and 2026, respectively...
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Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that on February 8, 2011 the U.S. Patent and Trademark Office issued U.S. Patent No. 7,884,187, entitled "Analysis of Amino Acid Copolymer Compositions."...
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Actavis Group, an international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Pantoprazole Sodium Delayed-Release Tablets...
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The Hyderabad based NATCO Pharma Limited is pleased to announce the acceptance of its Abbreviated New Drug Application for the generic version of Oseltamivir Phosphate capsules...
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Novartis's generics unit Sandoz is working on eight to 10 new biosimilar molecules to cement its position as leading maker of copycat versions of pricey biotech drugs, the unit's head told Handelsblatt....
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Teva Pharmaceutical Industries Ltd. rival Momenta Pharmaceuticals Inc. announced after Wall Street closed yesterday that the US Patent and Trademark Office issued a patent for the company's "Analysis of Amino Acid Copolymer Compositions." ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the United States District Court for the Southern District of Florida has ruled that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM Extended-Release products, do not infringe U.S. Patent No. 6,372,252...
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Protect Pharmaceutical Corporation announced today that it has completed the sale of two patents and patents-applications to Grunenthal GmbH, a German specialty pharmaceutical company that is a pioneer in pain drug discovery and research...
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The S.C. legislature is considering a bill that could lay the groundwork for AIDS patients on Medicaid to be treated with generic drugs, outraging patients and doctors who say the generics now available are significantly less effective than newer drugs not yet available in nonbrand form...
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Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration approval of its Abbreviated New Drug Application for its Fentanyl Transdermal System patch...
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Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, granted final approval for the Company's Abbreviated New Drug Application, for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon's Quixin ophthalmic solution...
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Approximately 64,000 patients with AIDS and 1,500 with hepatitis make use of tenofovir in Brazil...
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Panacea Biotec will soon launch a generic version of American drugmaker Abraxis Bioscience's breast cancer medicine Abraxane at half the price of the original drug which costs about 16,000 per vial...
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The following is excerpted from the complaint for patent infringement filed by Novartis on February 10, 2011 in the U.S. District Court for the District of Delaware...
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The generic pharmaceutical industry is positioned for an uptick in mergers and acquisitions, according to a report released today by the Generic and API Intelligence business of Thomson Reuters...
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The European Union has refuted assertions published recently by the media, claiming that the Free Trade Agreement under negotiation between India and the EU on generic drugs, would jeopardise production of generic medicines, including ARVs, and hence risk lives of millions of HIV patients, especially in poor countries...
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Perrigo Company announced that it has agreed to settle its Hatch-Waxman litigation relating to Minoxidil foam brought by Stiefel Research Australia Pty. Ltd., a GSK company...
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Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole Tablets, 50 mg and 200 mg, under a previously announced settlement and license agreement with Pfizer Inc...
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SOHM, Inc., a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories announced today that SOHM, India has received confirmation of a purchase order to supply 10 different generic drug formulations in Sri Lanka...
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Actavis Group, the international generic pharmaceuticals company, today announced the launch Anastrozole Actavis in the UK, Germany, Netherlands, Ireland, Italy, Sweden and Finland immediately after the patent expired on 11 and 12 February, respectively...
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On October 15, 2010 Genzyme Corporation filed a complaint in the United States District Court for the District of Massachusetts against Medicis Pharmaceutical Corporation and its affiliate Medicis Aesthetics Inc., alleging that Medicis is infringing on a patent held by Genzyme by marketing Restylane, Perlane, Restylane-L and Perlane-L in the United States...
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Big pharma's lobbying powers could be trumped by Obama's health reform agenda, at least as far as generic drugs are concerned...
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Generic drugmakers are getting their ducks in a row on user fees. At the end of the month, generics firms sit down with FDA to start hammering out a potential user-fee agreement...
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Sanofi-aventis and Genzyme Corporation announced today that they have entered into a definitive agreement under which sanofi-aventis is to acquire Genzyme for $74.00 per share in cash, or approximately $20.1 billion...
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In 2010, regulations were made pursuant to each of the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act...
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Sun Pharmaceutical Industries Ltd. must refrain from selling a generic version of Sanofi-Aventis SA's Eloxatin cancer drug until a court can rule on a contract dispute between the companies, a federal judge said...
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PDL BioPharma saw its shares drop 3.5% to $5.25 after the company said it had entered into a definitive settlement agreement with MedImmune, a US unit of Anglo-Swedish drug major (AstraZeneca), that resolves all legal disputes between them, including those relating to MedImmune's respiratory syncytial virus infection drug Synagis (palivizumab), and PDL's patents known as the Queen et al patents...
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Upsher-Smith Laboratories has recalled one lot of its generic warfarin product (Jantoven) because the bottles may contain tablets with the wrong doses...
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Drug firm Lupin today said it wants Japan to fast track and ease regulatory approvals to facilitate the entry of Indian generic drugs into the world's second largest pharmaceutical market...
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The European Medicines Agency has been formally notified by Sun Pharmaceutical Industries B.V. of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Topotecan SUN (topotecan) 1 mg and 4 mg powder for concentrate for solution for infusion...
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The European Medicines Agency has been formally notified by Merck Serono Europe Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicine Movectro (cladribine), 10 mg tablets...
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The European Parliament has given its backing to the proposed Directive on Falsified Medicines, setting the clock ticking on a two-year deadline for EU member states to implement the new legislation...
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US Patent Office Director David Kappos has announced his new Deputy Director: longtime intellectual property law professional Teresa Stanek Rea...
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Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration has approved ABILIFY (aripiprazole) as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder...
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Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a new indication for its topical eczema therapy, Protopic (tacrolimus ointment 0.03% and 0.1%)...
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A U.S. government proposal to bring cheaper generic drugs to the market more quickly and help curb health-care costs has triggered criticism from the European pharmaceutical sector...
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for its generic version of Adoxa (doxycyline monohydrate, 150 mg capsules)...
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There are now at least 3,000 Accutane lawsuits that have been filed in New Jersey state court alleging that makers of the acne medication failed to adequately warn about the risk of serious and debilitating bowel problems from Accutane...
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According to German media, the Icelandic generic company, Actavis is currently planning its expansion through future acquisitions...
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Abbott Laboratories has settled a patent litigation case against Ranbaxy Laboratories, allowing the Indian pharmaceutical firm to launch a generic version of the US drugmaker's cholesterol lowering medicine Tricor...
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Perrigo Company today announced that it has filed an Abbreviated New Drug Application for calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment, a generic form of Taclonex Ointment....
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Gilead Sciences, Inc. and Calistoga Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of medicines to treat cancer and inflammatory diseases, today announced the signing of a definitive agreement pursuant to which Gilead will acquire Calistoga for $375 million...
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Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Mylan Technologies Inc. claiming infringement of certain Noven patents by Mylan...
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Caraco Pharmaceutical Laboratories, Ltd. announced that on February 21, 2011 it entered into a merger agreement with Sun Pharmaceutical Industries Limited, Sun Pharma Global, Inc, a wholly-owned subsidiary of Sun Pharma organized under the laws of the British Virgin Islands and a newly-formed, indirect wholly-owned subsidiary of Sun Pharma incorporated in Michigan...
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Prasco Laboratories announced today it has signed a distribution and supply agreement with Shire US Manufacturing, Inc. for mesalamine controlled-release capsules...
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Hi-Tech Pharmacal Co., Inc. said that the US FDA granted final approval for the company's Abbreviated New Drug Application for gabapentin oral solution 250 mg/5 mL, the generic for Pfizer's Neurontin oral solution...
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The federal government approved a patent for Somaxon Pharmaceuticals' sleeping pill, giving the San Diego company protection from the maker of a generic version of the drug...
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Pozen Inc said U.S. health regulators will not grant a pediatric exclusivity to its Treximet migraine drug, a decision that can open up generic competition for the drug...
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Drug manufacturer Sanofi-Aventis has failed to alert federal regulators to reports of severe problems with some of its drugs, including the heart drug Multaq, and has been cited and ordered to fix its adverse event reporting system...
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With Generic Drugs gaining more and more importance each day, LX Pharma Inc had decided to get into the generic supplier group way back in 2007...
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A U.S. appeals court reversed a ruling that Abbott Laboratories' Humira arthritis drug infringed a patent owned by a Johnson & Johnson subsidiary and threw out a $1.67 billion damage award...
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Aurobindo Pharma Limited is pleased to announce that the company has received entative approval from the US Food & Drug Administration to manufacture and market Venlafaxine Hydrochloride Extended-release Capsules 37.5mg, 75mg and 150mg...
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Shire PLC., a global specialty biopharmaceutical company, Thursday announces that its subsidiaries Shire LLC and Shire Development Inc. have received a new Paragraph IV Notice Letter from Watson Laboratories, Inc...
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Leading lawyers from one of the most prestigious IP boutique firms in the UK, Powell Gilbert LLP, provide their expertise on recent developments in the Life Sciences sector...
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Australia's Senate Legal and Constitutional Committee is being urged to abandon patentable subject matter amendments in favor of the Intellectual Property Laws Amendments by the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and the trade group AusBiotech...
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Biocon founder Kiran Mazumdar-Shaw learned the intricacies of enzymes while studying how to make beer. Now Pfizer, the world's largest drugmaker, is tapping that knowledge to revive its insulin business...
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Pharma major Glenmark today said its US arm has received final approval from the US health regulator to market generic Levocetirizine Dihydrochloride tablets used for treating allergies in the American market....
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