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
The US District Court for the Southern District of New York has ruled in favor of Teva Pharmaceutical Industries in Copaxone patent infringement litigation. Teva filed lawsuit against Momenta/Sandoz and Mylan/Natco for infringement of ...
Tags: patent, Teva Pharmaceutical Industries, FDA
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 ...
Mylan Pharmaceuticals has filed suit against FDA seeking to overturn a decision that gives Teva Pharmaceuticals 180-day exclusivity to market the generic version of its affiliate Cephalon's Provigil. Mylan alleges Teva did not keep up ...
Merck, known as MSD outside the US and Canada, has won Zetia (ezetimibe) / Vytorin (ezetimibe/simvastatin) patent infringement suits against Mylan Pharmaceuticals. The US District Court has ruled in favor of Merck in two jointly ...
Mylan, a generic pharmaceutical manufacturer, will spend $100m in Ireland over the next five years to expand its operations in the cities of Dublin and Galway. Through the investment, Mylan is expected to add more than 500 new positions ...
Mylan has announced the launch of Ibandronic Acid Film Coated Tablets POM, 150mg, to treat osteoporosis in the UK and Italy. The product, launched by Mylan's subsidiaries based in the UK and Italy, is the generic version of Roche's ...
Tags: Mylan, ibandronic acid, ibandronic acid film coated tablets POM
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 ...
Mylan Institutional business has won final FDA approval for its abbreviated new drug application (ANDA) for preservative-free Thiamine Hydrochloride Injection, 100mg/ml, packaged in 200mg/2ml multiple-dose vials. Mylan is shipping the ...
Mylan Pharmaceuticals has received final FDA approval for its abbreviated new drug application (ANDA) for Lithium Carbonate Extended-release tablets USP, 300mg. Mylan has announced immediate shipment of the generic version of Noven ...
Tags: new drug, Lithium Carbonate Extended-release tablets USP, manic episodes