Generics Industry News Search
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July 2012 News Archive |
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Janssen Research & Development, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the use of the investigational drug Bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults...
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Bristol-Myers Squibb Company and Amylin Pharmaceuticals announced today that Bristol-Myers Squibb will acquire Amylin for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $5.3 billion...
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Dr. Reddy's Laboratories announced today that it has launched Ibandronate sodium tablets (150 mg), a bioequivalent generic version of BONIVA tablets...
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Cornerstone Therapeutics, a specialty pharmaceutical company focused on acquiring, developing and commercialising proprietary products for the hospital, and related specialty markets, today announced that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone polistirex and Chlorpheniramine polistirex extended-release suspension product...
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Lupin won an appeals court ruling yesterday that lets it continue selling a generic version of the Shionogi Pharma diabetes drug Fortamet...
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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 Lithium carbonate extended-release tablets...
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Pharma major, Lupin, announced today that its subsidiary, Lupin Pharmaceuticals has received approval for its Norgestimate and Ethinyl estradiol tablets...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has launched Desloratadine tablets, 5 mg, the generic version of Schering-Plough's Clarinex allergy medication...
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Eli Lilly and Company announced today that it has met the United States Food and Drug Administration (FDA) requirements for paediatric exclusivity for Cymbalta (Duloxetine HCl)...
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Shares in Mayne Pharma have dropped by more than six per cent amid news the pharmaceuticals company is being sued in the United States...
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ACETO Corporation, a global leader in the marketing, sales and distribution of pharmaceutical active ingredients and intermediates, finished dosage form generics, nutraceutical products, agricultural protection products and specialty chemicals, today announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched the 200 mg/325 mg strengths of Carisoprodol and Aspirin tablets...
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Cubist Pharmaceuticals, a maker of antibiotic medicines, sued Hospira for patent infringement over plans to market a generic version of Cubicin, a drug used to combat the MRSA flesh-eating bacterium...
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Teva Pharmaceutical Industries announced that the United Kingdom High Court of Justice issued a decision in favor of Teva in a patent litigation proceeding against Generics (UK) Limited, a subsidiary of Mylan Laboratories...
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Watson Pharmaceuticals today announced that its subsidiary Watson Laboratories - Florida has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Diclofenac sodium and Misoprostol delayed-release tablets, the generic equivalent to G.D. Searle's Arthrotec...
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The pharma sector may soon be embroiled in another bloody patent battle...
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Watson Pharmaceuticals today announced that its subsidiary Watson Laboratories has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice ONE DOSE (Levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step...
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Par anticipates shipping generic Trandate in August...
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Par Pharmaceutical Companies announced today that it has entered into a definitive merger agreement to be acquired by an affiliate of TPG in a transaction with an equity value of $1.9 billion...
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Swiss drugmaker Novartis has won U.S. antitrust approval to close its purchase of generic dermatology products maker Fougera...
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Gilead Sciences today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (Emtricitabine and Tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk...
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RegeneRx Biopharmaceuticals today announced that it has entered into a licensing agreement with Lee's Pharmaceutical (HK), headquartered in Hong Kong, for the license to Lee's of RegeneRx's Thymosin Beta 4-based products, including the Company's RGN-259, RGN-352 and RGN-137 product candidates, in China (including Hong Kong and Macau) and Taiwan...
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Mylan today announced that it and its subsidiary, Mylan Pharmaceuticals, have entered into a settlement agreement with Somaxon Pharmaceutical that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Doxepin hydrochloride tablets, 3 mg and 6 mg, which is the generic version of Somaxon's Silenor, indicated for the treatment of insomnia characterised by difficulty with sleep maintenance...
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Vivus today announced that the U.S. Food and Drug Administration (FDA) has approved Qsymia (pronounced Kyoo sim ee' uh) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia)...
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pSivida, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the National Security Agency of Medicines and Health Products (L'Agence Nationale de Securite du Medicament et des Produits de Sante) has granted marketing authorisation to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies...
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Dr. Reddy's Laboratories announced today that it has launched Atorvastatin calcium tablets 10 mg, 20 mg, 40 mg and 80 mg a bioequivalent generic version of Lipitor...
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Swiss drugmaker Novartis sued Sun Pharmaceutical to block it from selling generic forms of the bone-strengthening medications Zometa and Reclast...
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Somaxon Pharmaceuticals, a specialty pharmaceutical company, today announced that it has entered into a settlement agreement with Cadila Healthcare and Zydus Pharmaceuticals (USA) to resolve pending patent litigation involving Silenor 3 mg and 6 mg tablets...
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Somaxon Pharmaceuticals said Tuesday that it has entered into separate settlement arrangements with Mylan and its subsidiary, Mylan Pharmaceuticals and Par Pharmaceutical Companies and its subsidiary Par Pharmaceutical to resolve pending patent litigation involving Silenor 3 mg and 6 mg tablets...
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Pfizer, the world's largest drugmaker, convinced a U.S. judge that its patents for the pain- drug Lyrica are valid and infringed, giving it exclusive sales rights until 2018...
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Myriad Genetics, owner of patents related to genes linked to hereditary cancer risks, is trying to claim legal ownership of a product of nature, the American Civil Liberties Union told a U.S. appeals court today...
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The US Food and Drug Administration (FDA) has approved Afinitor (Everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with Exemestane after failure of treatment with Letrozole or Anastrozole...
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Sandoz has completed its USD 1.525 billion acquisition of specialty US dermatology company Fougera Pharmaceuticals on a cash and debt free basis...
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Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Metformin hydrochloride extended-release (ER) tablets...
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Sagent Pharmaceuticals today announced the launch of Oxacillin for injection, USP, in three latex-free, preservative-free vial presentations...
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Qualitest Pharmaceuticals today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam extended-release tablets...
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A Delaware jury found Genzyme liable for inducing infringement of U.S. Patent 7,011,831, assigned to Shelbyzyme...
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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 Itraconazole capsules, 100 mg...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Epiduo (Adapalene and Benzoyl peroxide) gel, 0.1% / 2.5%...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Levalbuterol tartrate inhalation aerosol,0.045 mg/actuation...
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Intellipharmaceutics International today announced that it had reached an agreement with AstraZeneca to settle all outstanding patent litigation concerning its abbreviated new drug application (ANDA) for the commercialisation in the United States of a generic version of Seroquel XR (Quetiapine fumarate extended-release) tablets...
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French pharma company Servier has been formally charged by the European Commission of blocking the entry of generic versions of its cardiovascular medicine Coversyl/Aceon (Perindopril) in collusion with four generic drugmakers...
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