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
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
Takeda Pharmaceutical Company and H. Lundbeck have submitted a new drug application (NDA) to the FDA for vortioxetine (Lu AA21004), an investigational drug for the treatment of major depressive disorder (MDD). Vortioxetine is under ...
Tags: Takeda Pharmaceutical Company, major depressive disorder, MDD
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
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
Kyowa Hakko Kirin, Orexo's partner, has filed a new drug application (NDA) seeking Japanese approval for KW-2246 as cancer pain medication. The sublingual formulation of fentanyl earlier gained approval in US, EU and Canada as cancer ...
Tags: new drug application, cancer pain medication, pharmaceutical product
Bayer HealthCare has submitted has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its regorafenib drug. The oral multi-kinase inhibitor regorafenib is used for the treatment of metastatic and ...
Tags: NDA, FDA, inhibitor, metastatic, GIST
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
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
The FDA has approved the stretched dose range for Sunovion Pharmaceuticals' Latuda for the treatment of patients with schizophrenia. After the review of the supplemental new drug application (sNDA), which was submitted in June 2011, ...
Tags: FDA, Schizophrenia, dose range for Latuda
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 ...