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January 2013 News Archive |
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Drug maker Aurobindo Pharma today said it has received final approval from the US Food and Drug Administration to manufacture and market Rizatriptan Benzoate tablets used in the treatment of migraine...
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Company also launching immediate-release version Maxalt Tablets...
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Dr. Reddy's Laboratories announced today that is has launched Finasteride Tablets (1 mg), a bioequivalent generic version of Propecia (Finasteride) tablets in the US market on January 02, 2013. Dr. Reddy's ANDA for Finasteride, 1 mg tablets has been awarded a 180-day period of marketing exclusivity in the U.S. on 2 Jan, 2013...
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Forest Laboratories announced today that they have entered into a settlement agreement with Glenmark in patent infringement litigation brought by Forest in response to Glenmark's abbreviated new drug application seeking approval to market generic versions of Forest's Bystolic (nebivolol) tablets...
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Watson Pharmaceuticals today announced that its subsidiary Watson Laboratories has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Tranexamic acid tablets, the generic equivalent to Ferring Pharmaceuticals' Lysteda...
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Impax Laboratories today announced that it is commencing shipment of Oxymorphone hydrochloride extended-release tablets, through Global Pharmaceuticals, Impax's generics division...
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Perrigo Company today announced that it has made initial shipments distributing Cumberland Pharmaceuticals's authorised generic form of Acetadote (Acetylcysteine) injection...
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Hikma Pharmaceuticals, the fast growing multinational pharmaceutical group, today announced the approval of its New Drug Application (NDA) for Phenylephrine HCl Injection, USP, 10mg/mL, 1mL vial by the US Food and Drug Administration (FDA)...
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InnoPharma today announced U.S. FDA approval of its Abbreviated New Drug Application (ANDA) for Acetylcysteine injection, indicated to prevent or lessen hepatic injury following an acetaminophen overdose...
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Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 25mg, 50mg, 100mg, 200mg and 300mg extended release tablets of Lamotrigine, which is used in treatment of epilepsy...
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ViroPharma (VPHM)'s lawsuit against the U.S. Food and Drug Administration over generic forms of its antibiotic Vancocin was dismissed by a federal judge...
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The U.S. Supreme Court left intact a ruling that lets Otsuka Holdings' pharmaceutical unit block generic competition to its schizophrenia drug Abilify in the U.S. until April 2015...
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Perrigo today announced that it has begun commercial shipments of Betamethasone valerate foam 0.12%, the generic equivalent of Luxiq foam, consistent with the date certain launch settlement previously announced...
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Drug set for launch in the first quarter of this year...
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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 Felodipine extended-release tablets USP 2.5mg, 5mg, and 10mg...
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Par Pharmaceutical today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg and 300 mg extended-release (ER) tablets...
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Par Pharmaceutical was sued for patent infringement by Horizon Pharma over a generic version of the drug Duexis, used to treat arthritis...
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Aurobindo Pharma is pleased to announce that the company has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Oxacillin for injection USP, packaged in 1g and 2g vials (ANDA 201539) and Oxacillin for injection USP 10g/Vial Pharmacy Bulk Package (ANDA 201538)...
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Teva UK has announced the launch of Cyclizine tablets, a new generic therapy for nausea and other similar conditions...
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Watson Pharmaceuticals today confirmed that Actavis South Atlantic, 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 Oxymorphone hydrochloride extended-release tablets...
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Pharma company, Lupin, Thursday said it has received approval from the US health regulator to market its oral contraceptive drug, Levonorgestrel tablets USP, in the American market...
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Watson Pharmaceuticals today announced that the company has adopted Actavis as its new global name and will today begin trading under a new symbol - ACT - on the New York Stock Exchange...
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Dr. Reddy's Laboratories announced today that it has launched Desloratadine ODT (2.5 mg & 5 mg), a bioequivalent generic version of Clarinex Reditabs (Desloratadine)...
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AbbVie, the drug unit that split from parent Abbott Laboratories on Jan. 1, sued Indian generic drugmaker Sun Pharmaceutical Industries for infringing a patent for Zemplar, used to treat kidney patients...
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Amneal Pharmaceuticals, today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., to acquire exclusive distribution rights to Hanmi's new drug application (NDA), currently under FDA review, for Esomeprazole strontium delayed-release capsules...
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Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Mupirocin calcium cream USP, 2%...
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Specialty pharmaceutical company Allergan won a round in a patent fight against two generic drug makers on Monday when an appeals court found a key portion of the patent for its glaucoma drug, Lumigan, was valid...
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Nuvo Research announced today that it has entered into a settlement agreement with Apotex respecting patent infringement litigation brought by Nuvo and Nuvo's U.S. licensing partner, Mallinckrodt in response to Apotex's filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Pennsaid (Diclofenac sodium topical solution) 1.5% w/w...
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The European Commission has informed the pharmaceutical companies Johnson & Johnson and Novartis of its objections regarding an agreement concluded between their respective Dutch subsidiaries on Fentanyl, a strong pain-killer...
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Actavis today confirmed that the United States District Court for the District of Delaware has found United States Patent No. 5,100,899 (the '899 Patent) valid and infringed by Actavis' generic version of Pfizer's Rapamune (Sirolimus)...
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