The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia
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
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
Pluristem Therapeutics, a developer of placenta-based cell therapies, is seeking FDA orphan drug status for its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia. Pluristem earlier received an orphan drug status from the ...
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