Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. The approved ...
Tags: Medicine, Etomidate Injection, Hospira's Amidate injection
The USFDA has accepted Exelixis' new drug application for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer and granted priority review designation. ...
Tags: FDA, new drug application, Priority Review Designation
Qualitest Pharmaceuticals, a generic pharmaceutical company, has won the US Food and Drug Administration (FDA) approval for abbreviated new drug application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg. The ...
GlaxoSmithKline (GSK) and Theravance have announced the regulatory submissions for furoate FF/vilanterol VI (FF/VI) to treat chronic obstructive pulmonary disease (COPD) in the US and Europe. The companies also announced regulatory ...
The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard ...
Tags: US FDA, Bayer HealthCare, NDA
Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate). Janssen-Cilag International NV has also sent a type II variation to the European Medicines ...
Watson Pharmaceuticals said Sunovion Pharmaceuticals has challenged Watson Laboratories filing of Abbreviated New Drug Application(ANDA)with the US Food and Drug Administration(FDA)seeking approval for marketing Levalbuterol Tartrate ...
Tags: Sunovion, FDA, Watson Laboratories
Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
Ligand Pharmaceuticals partner GlaxoSmithKline has submitted regulatory applications in the US and European Union for the use of eltrombopag (Promacta/Revolade) to increase platelet counts in patients with hepatitis C. A supplemental ...
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension ...
Tags: FDA approval, pharmaceutical product, generic antitussive product
Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA. Cabozantinib is ...
Tags: submission of new drug application, FDA, pharmaceutical product
Medivation and Astellas Pharma have announced the submission of new drug application (NDA) for enzalutamide (formerly MDV3100) to the FDA. The enzalutamide has been studied in patients with castration-resistant prostate cancer who ...
Tags: enzalutamide, new drug application, pharmaceutical product
Digestive Care (DCI) has gained FDA approval for its new drug application (NDA) for Pertzye, a pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres. Pertzye is indicated for the treatment of Exocrine ...
Astellas Pharma has announced favorable US court ruling in patent infringement case for OSI Pharmaceuticals, Genentech, a member of the Roche Group, and Pfizer. The US District Court for the District of Delaware has found both the patents ...
Tags: Astellas Pharma, Mylan, lawsuit