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   February 2013 News Archive news archive  


01/02/2013  Perrigo commences launch of Clobetasol emulsion propionate foam, 0.05% news archive
Perrigo Company today announced that it has launched Clobetasol emulsion propionate foam, 0.05%, the generic equivalent of Olux -E Foam, 0.05%...
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01/02/2013  Opportunities for biosimilars as patent protection drops: report news archive
Significant opportunities are expected to open up for pharmaceutical companies in the biosimilar segment, as biological drugs with a market value of over $50 billion are slated to shed their patent protection in the US alone in the next six years...
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02/02/2013  IGI Laboratories acquires Econazole nitrate cream news archive
IGI Laboratories, Inc a New Jersey based generic topical pharmaceutical company, today announced it has entered into an agreement to purchase the topical pharmaceutical product Econazole Nitrate Cream 1% from Prasco, a privately-held pharmaceutical company located in Ohio...
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04/02/2013  FDA approves generic version of cancer drug Doxil news archive
Health regulators have approved a generic version of the cancer drug Doxil in a move that could ease a months-long shortage that has threatened the lives of thousands of patients...
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05/02/2013  Perrigo Confirms FDA Approval For Testosterone Gel 1% news archive
Perrigo announced that it has received U.S. Food and Drug Administration approval for its New Drug Application (NDA) for Testosterone gel 1%. Perrigo's NDA included a bioequivalence study that compared its product to AbbVie's AndroGel 1%...
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06/02/2013  Elite Pharmaceuticals annouces FDA approval of supplemental application for Naltrexone news archive
Elite Pharmaceuticals announced today that on January 31, 2013, the U.S. Food and Drug Administration approved the Company's supplemental application for the manufacturing and packaging of Naltrexone hydrochloride 50 mg tablets...
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07/02/2013  Atovaquone Proguanil Malarone patent revoked & Glenmark launches first UK generic news archive
Glenmark announces the first generic launch of Atovaquone Proguanil in the UK following the revocation of the Malarone patent in the High court in the UK...
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08/02/2013  Sucampo files patent infringement lawsuit against Anchen Pharmaceuticals and Par Pharmaceuticals news archive
Sucampo Pharmaceuticals today announced that it, its affiliate Sucampo, Takeda Pharmaceutical Company, and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Par Pharmaceuticals, and Par Pharmaceutical Companies (collectively Anchen) related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the U.S. Food and Drug Administration (FDA) to market a generic version of Amitiza (Lubiprostone) oral capsules, 8 mcg and 24 mcg...
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08/02/2013  Impax and Shire settle litigation concerning supply of authorised generic Adderall XR news archive
Impax today announced that it has settled all pending litigation with Shire relating to supply of its authorised generic Adderall XR under the parties' License and Distribution Agreement that was signed in January 2006...
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11/02/2013  Perrigo acquires U.K.-based Rosemont Pharmaceuticals for approximately $283 million news archive
Perrigo today announced that it has signed a definitive merger agreement and has completed the acquisition of Leeds, U.K.-based Rosemont Pharmaceuticals for approximately $283 million in cash...
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11/02/2013  Putney launches first FDA approved veterinary generic of Simplicef news archive
Putney Inc., a rapidly growing pharmaceutical company focused on the development and sale of generic prescription medicines for pets, has launched generic veterinary Cefpodoxime Proxetil tablets...
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11/02/2013  Beximco Pharma enters EU market, starting its export to Germany and Austria news archive
Beximco Pharmaceuticals Limited has commenced export of medicines to Europe...
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11/02/2013  FDA may change warning regs for generic labels news archive
Last year, the US Supreme Court ruled generic drug makers are not required to strengthen labeling even when alerted to side effects...
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12/02/2013  Bristol-Myers loses Baraclude patent fight with Teva news archive
A U.S. court has struck Baraclude from the patent list...
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13/02/2013  Mylan enhances partnership with Biocon through strategic collaboration for Insulin products news archive
Mylan today announced that it has entered into a definitive agreement with Biocon for an exclusive strategic collaboration on the development and commercialisation of generic versions of three insulin analog products...
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14/02/2013  Teva faces possible damages from selling generic Protonix news archive
Teva may be on the hook for up to $2.1 billion in damages because it sold generic copies of Pfizer's heartburn reliever Protonix before the drug's U.S. patent exclusivity expired in 2011...
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14/02/2013  Teva announces FDA approval of generic Adderall news archive
Teva announced today that the U.S. Food and Drug Administration has approved its generic version of Shire's Adderall Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder...
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14/02/2013  Actavis reaches settlement with Mallinckrodt over Exalgo news archive
Actavis, Inc. today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release) tablets...
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14/02/2013  FDA grants final approval to Breckenridge's Pioglitazone Hydrochloride news archive
Breckenridge Pharmaceutical. announced today the immediate launch of Pioglitazone Hydrochloride Tablets...
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15/02/2013  Actavis wins patent appeal for generic to Teva' s Fentora news archive
Actavis' s generic version of the painkiller Fentora wouldn't infringe two patents owned by Teva' s Cephalon unit, a U.S. appeals court ruled today...
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15/02/2013  Torrent Pharma gains on USFDA nod for generics of Actos news archive
Torrent gained more than one percent intraday on Friday as the company received approval from US FDA for generics of Actos and Actoplus Met...
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15/02/2013  Seroquel XR patent upheld, protecting AstraZenca blockbuster news archive
AstraZeneca's new CEO Pascal Soriot had to start the year giving shareholders tough news about the U.K. company...
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15/02/2013  2013 should bring clarity to analysis of settlements of pharmaceutical patent litigation news archive
The Federal Trade Commission (FTC) recently filed a brief with the U.S. Supreme Court in a case that promises to bring some clarity to the analysis of settlements of pharmaceutical patent litigation...
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15/02/2013  Perrigo confirms first to file patent challenge for generic version of Testosterone gel 1.62% news archive
Perrigo Company announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for Testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing...
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16/02/2013  Generic drug lawsuits: Bernstein Liebhard LLP comments on possible FDA rule change that could eliminate pre-emption news archive
The FDA is considering a rule change that could pave the the way for individuals allegedly injured by generic versions of popular medications, including Fosamax, to pursue generic drugs lawsuits against their manufacturers, Bernstein Liebhard LLP reports...
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19/02/2013  Sergeant's pet care products unleashes Pronyl OTC flea and tick spray for dogs and cats news archive
Sergeant's Pet Care Products, a leader in the pet supplies industry, announces the release of Sergeant's Pronyl OTC Flea and Tick Spray for Dogs and Cats, the only generic equivalent to Frontline Spray currently available...
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19/02/2013  Gilead and Teva reach settlement agreement in Viread patent litigation news archive
Gilead Sciences, today announced that Gilead and Teva have reached an agreement in principle to settle the ongoing patent litigation concerning the patents protecting Viread, a treatment for HIV infection and chronic hepatitis B...
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19/02/2013  "Biosimilar" drug bill passes news archive
The battle over biosimilar drugs moved ahead today in the Florida House, as the Health Quality Subcommittee approved a bill that would create standards for using a new wave of pharmaceutical products that are expected to gain in popularity in the next few years...
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19/02/2013  Sandoz launches an authorised generic version of Argatroban injection news archive
Sandoz today announced the US launch of an authorised generic version of Eagle Pharmaceuticals ready-to-use Argatroban injection 50 mg/50mL, aqueous solution (1 mg/mL)...
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21/02/2013  Bayer sues Generic Health over Isabelle contraceptive patents news archive
Pharmaceuticals company Bayer is suing an Australian company for selling generic versions of its patented oral contraceptive drug...
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22/02/2013  Ranbaxy to resume generic Lipitor production for U.S news archive
Indian generic drugmaker Ranbaxy said on Friday it will resume production of its version of Pfizer's cholesterol fighter Lipitor for sale in the United States after resolving the issues that led to a November recall...
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22/02/2013  Biotechs, pharmacists split on biosimilars bill news archive
Maryland among states considering restrictions...
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22/02/2013  Pfizer asks US Court to reconsider generic Reglan ruling news archive
Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers...
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23/02/2013  Mylan launches innovative portfolio of antiretroviral products for treatment of HIV/AIDS in South Africa news archive
Mylan, today announced that its subsidiary in South Africa, Mylan (Proprietary) Limited, has launched a comprehensive portfolio of antiretroviral (ARV) products. South Africa has the world's largest HIV/AIDS population, with approximately 5.6 million1 people living with the disease and an estimated 1.7 million2 people receiving treatment...
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25/02/2013  Reckitt loses U.S. bid to block generic heroin addict drug news archive
U.S. regulators approved two generic versions of Reckitt Benckiser's heroin addiction drug and rejected its bid to block rival products on the grounds that stricter packaging rules were needed to protect children...
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25/02/2013  Viropro and Oncobiologics sign emerging markets biosimilars deal news archive
Viropro and Oncobiologics announced today the signing of a biosimilar collaboration agreement...
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25/02/2013  Actavis' generic Suboxone Receives FDA Approval news archive
Actavis today announced that it has received approval from the U.S. FDA on its ANDA for Buprenorphine HCl and Naloxone HCl dihydrate SL tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone...
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25/02/2013  Amneal receives FDA approval for generic Suboxone news archive
Amneal, the 7th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone sublingual tablets for maintenance treatment of opioid drug dependence...
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25/02/2013  Blood drug woes could weigh on FDA and its approval of new copycat biologic medicines news archive
The announcement last night that Affymax is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward...
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25/02/2013  Mylan launches generic Antara capsules news archive
Mylan today announced that it has begun shipping Fenofibrate Capsules USP, 43 mg and 130 mg...
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25/02/2013  Claris Lifesciences gets ANDA approvals for Ondensetron injection news archive
Claris Lifesciences announced that it has received two Abbreviated New Drug Application approvals for Ondensetron Injection in the US...
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27/02/2013  Mylan acquires Agila to create leading global injectables platform news archive
Mylan today announced that it has signed a definitive agreement to acquire Agila Limited, a developer, manufacturer and marketer of high-quality generic injectable products, from Strides Arcolab for $1.6 billion in cash...
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