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   December 2012 News Archive news archive  


05/12/2012  Strides Arcolab and Lilly enter strategic partnership to deliver high-quality, branded generic cancer medicines for emerging markets news archive
Under the partnership agreement, Lilly will have the rights to market cancer medicines across the emerging markets...
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05/12/2012  Mylan launches generic version of Atacand HCT news archive
Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Candesartan cilexetil and Hydrochlorothiazide tablets, 16/12.5 mg, 32/12.5 mg and 32/25 mg...
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06/12/2012  Lawsuit challenges Ranbaxy's rights to generic drug news archive
The Swiss drug maker Novartis had been bracing all year for the day in late September when Diovan, its top-selling blood pressure drug, would lose patent protection and a cheaper generic version would become available...
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11/12/2012  Lotus Pharmaceutical submits generic Xenical ANDA with FDA news archive
Lotus Pharmaceutical has confirmed its submission of Abbreviated New Drug Application for Orlistat capsules...
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11/12/2012  ACETO subsidiary, Rising Pharmaceuticals, launches first generic version of Grifulvin V news archive
ACETO, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, launched the first generic version of the 500 mg strength (microsize) of Griseofulvin tablets USP, an FDA approved generic version of Valeant Pharmaceutical's Grifulvin V...
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14/12/2012  Crestor US patent upheld by Court of Appeals for the Federal Circuit news archive
AstraZeneca announced today that the Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the US substance patent protecting Crestor (Rosuvastatin calcium) (RE37,314 - the '314 patent) is valid and enforceable...
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16/12/2012  Teva enters agreement with Handok to establish business venture with significant presence in Korean pharmaceutical market news archive
Teva Pharmaceutical (TEVA) and Handok Pharmaceuticals announced today their agreement to establish a business venture in South Korea, allowing Teva to gain entrance into the Korean pharmaceutical market, currently valued at approximately USD 14 billion...
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17/12/2012  Sun Pharma acquires URL generic business from Takeda news archive
Sun Pharmaceutical Industries announced today that Caraco Pharmaceutical Laboratories, its wholly-owned subsidiary, has entered into a definitive agreement with Takeda Pharmaceuticals U.S.A., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, to buy the URL Pharma generic business...
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18/12/2012  Mylan launches generic version of Qualaquin capsules news archive
Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Quinine sulfate capsules USP, 324 mg...
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19/12/2012  Breckenridge announces approval for Lansoprazole DR caps news archive
Breckenridge Pharmaceutical announced today the immediate launch of prescription Lansoprazole delayed-release capsules...
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20/12/2012  Mylan announces Comtan settlement agreement news archive
Mylan today announced that its subsidiary Mylan Pharmaceuticals has entered into a settlement agreement with Orion that will resolve patent litigation related to Entacapone tablets, 200 mg...
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20/12/2012  Acura submits Investigational New Drug Application news archive
Acura Pharmaceuticals today announced that an Investigational New Drug application (IND) has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's Hydrocodone bitartrate with Acetaminophen formulated with Aversion Technology...
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27/12/2012  Bristol-Myers sues Dr. Reddy's over patent row news archive
U.S.-based drug maker Bristol-Myers Squibb has filed a patent infringement case against Dr. Reddy's Laboratories (DRL) over cancer drug Ixempra...
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28/12/2012  Mylan suit against FDA over generic heart drug dismissed news archive
Mylan's lawsuit against the U.S. Food and Drug Administration for withholding approval for the company to sell a generic version of Novartis AG's heart pill Diovan was dismissed by a federal judge in Washington...
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28/12/2012  Watson confirms Velcade patent challenge news archive
Watson Pharmaceuticals, today confirmed that Actavis which was acquired by Watson in October, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Bortezomib...
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28/12/2012  Mylan launches generic Nordette tablets news archive
Mylan today announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levonorgestrel and Ethinyl Estradiol tablets USP, 0.15 mg/0.03 mg...
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28/12/2012  Mylan launches generic Dilantin chewable tablets news archive
Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Phenytoin chewable tablets USP, 50 mg...
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31/12/2012  FDA grants accelerated approval for Sirturo [Bedaquiline] as part of combination therapy to treat adults with pulmonary multi-drug resistant tuberculosis news archive
Janssen Therapeutics, Division of Janssen Products, today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Sirturo (Bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults...
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31/12/2012  Watson Pharmaceuticals: Watson launches generic Biaxin XL news archive
Watson Pharmaceuticals, a leading specialty pharmaceutical company, announced today it has launched Clarithromycin extended-release tablets, USP in the 500 mg strength. Watson's Clarithromycin extended-release product is the generic equivalent to Abbott's Biaxin XL, which is indicated to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria...
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31/12/2012  Mallinckrodt launches generic version of Concerta in U.S. news archive
Mallinckrodt, the Pharmaceuticals business of Covidien, today announced that it has received approval from the U.S. Food and Drug Administration to manufacture and market a generic version of Concerta (Methylphenidate HCl) extended-release (ER) tablets USP in 27, 36 and 54 mg dosage strengths...
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