Mylan Pharmaceuticals has signed a settlement agreement with Somaxon Pharmaceutical to resolve patent litigation related to generic version of Somaxon's Silenor. The litigation is regarding Mylan Pharmaceuticals' abbreviated new drug ...
Tags: litigation, generic version of Somaxon's Silenor, ANDA
Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...
Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD
Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg. The product is the generic version ...
Teva Pharmaceutical Industries has entered into a settlement agreement related to Nuvigil patent infringement litigation with Mylan. Under the agreement, Mylan is allowed to sell generic versions of 50mg, 150mg, and 250mg Nuvigil in June ...
Tags: Nuvigil, armodafinil tablets, Teva Pharmaceutical Industries, Mylan
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product. The product, a generic version of Novartis' Lescol ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
US based Watson Pharmaceuticals has filed a legal case against US Food and Drug Administration's (FDA) decision regarding the company's exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets). ...
Tags: Watson Pharmaceuticals, Actos, Pioglitazone Hydrochloride
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has won FDA abbreviated new drug application approval for Diclofenac Sodium and Misoprostol Delayed-Release Tablets. The company plans to launch Diclofenac Sodium and ...
Tags: Watson Laboratories
Perrigo Company, a healthcare company, has won final FDA approval for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will immediately begin the shipment of Morphine sulfate oral solution, a ...
Tags: Perrigo Company, morphine sulfate, morphine sulfate oral solution
America's Impax Laboratories has begun the challenging process against the suit filed by two companies for patent infringement over a generic version of Opana® ER (oxymorphone hydrochloride extended-release) drug. Impax ...
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg). The Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg) ...
Tags: ONE DOSE, levonorgestrel tablet, Watson Pharmaceuticals
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) of Trospium Chloride Extended-release Capsules. Watson anticipates beginning the shipment of the ...
Tags: FDA, Trospium Chloride Extended-release Capsules, pharmaceutical product
Mylan has launched Lithium Carbonate Extended-release Tablets USP, 450 mg following the final approval from the US Food and Drug Administration (FDA). The drug is used to treat manic episodes of manic depressive illness. According to ...
Tags: Mylan, lithium carbonate extended-release tablets, treat manic episodes
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Nevirapine Tablets USP, 200mg and initiated the shipment of the product. The generic version of Boehringer Ingelheim's Viramune is ...
Tags: Mylan pharmaceuticals, ANDA, ARV
Mylan's subsidiary, Mylan Pharmaceuticals, has settled Provigil litigation with Teva Pharmaceutical USA. The settlement follows the Mylan litiagtion against the US Food and Drug Administration (FDA) regarding Mylan's abbreviated new drug ...