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
Actavis Group, a generic pharmaceuticals company, has gained FDA approval for Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg. The company has started distribution of the generic version of GlaxoSmithKline's Requip XL. ...
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene
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 ...
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
Novartis, Incyte's strategic collaborator, has received the European Commission approval for Jakavi (INC424, ruxolitinib), an oral JAK 1 and JAK 2 inhibitor to treat patients with myelofibrosis. The oral JAK 1 and JAK 2 inhibitor ...
Horizon Pharma RAYOS (prednisone) delayed-release tablets have received the US Food and Drug Administration (FDA) approval. The approved drug is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis ...
Tags: Horizon Pharma RAYOS delayed-release tablets, rheumatoid arthritis, RA
Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with ...
Tags: Qiagen, FDA, molecular companion diagnostic product, test kit
The US District Court for the District of New Jersey has ruled against Merck, known as MSD outside the US and Canada, in a patent litigation against Apotex. The patent at issue in the case covers the active ingredient in Nasonex, ...
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
Proacta, a San Diego based biotechnology company, has announced FDA approval of investigational new drug (IND) application for PR610, a hypoxia-activated irreversible multi-kinase inhibitor, for the treatment of cancer. With the IND ...
Tags: investigational new drug, IND
The US Food and Drug Administration (FDA) has granted approval to HeartWare International's miniaturized ventricular assist system. The HeartWare system, which includes a HVAD circulatory assist device with a sintered inflow cannula, ...
Tags: ventricular assist system, cardiac transplantation, FDA
GlaxoSmithKline (GSK) and XenoPort have gained FDA approval for Horizant (gabapentin enacarbil) extended-release tablets for postherpetic neuralgia (PHN). A single 12-week principal efficacy trial and two supportive studies that met their ...
Sunland's peanut butter plant in New Mexico,which has been linked to a salmonella outbreak in the US,remains idle as the management waits for federal clearance to begin operations. Sunland suspended the operations of the plant and ...
Tags: peanut butter, idle, salmonella, FDA
TherapeuticsMD, a parent company of vitaMedMD, has filed additional patent applications for its prescription products to treat menopausal symptoms and related conditions. The patent applications concern its proprietary formulation ...
Tags: TX12001HR, TX12002HR, TX12003HR, TherapeuticsMD