There's been a lot of buzz lately about the safety of energy drinks and shots. Following reports of harmful reactions and even deaths possibly associated with the products, two U.S. senators recently released a letter from the FDA stating ...
Tags: Energy Drinks, Drinks
AVEO Oncology and Astellas Pharma have announced FDA acceptance of tivozanib new drug application(NDA)filing for the treatment of advanced renal cell carcinoma(RCC). According to the development and commercialization deal signed between ...
Tags: AVEO Oncology, Astellas Pharma, FDA, RCC, NDA
US-based Biomedical Advanced Research and Development Authority (BARDA) has granted $50.2m to Elusys Therapeutics for the development of investigational ETI-204 (Anthim) agent, designed for the treatment of inhalational anthrax following a ...
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 ...
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nuvo Research's Pliaglis (lidocaine/tetracaine) 7%/7% cream. Pliaglis, a topical local anesthetic cream forms a pliable peel on the skin ...
The Anti-Infective Drugs Advisory Committee (AIDAC) to the US Food and Drug Administration (FDA) has recommended the use of Novartis's tobramycin inhalation powder (TIP) to treat cystic fibrosis (CF) patients whose lungs contain bacteria ...
Perrigo Company has received final FDA approval for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac gel. Duac Gel is indicated for the ...
Tags: perrigo company, ANDA, patent litigation
The FDA has cleared INJEX Pharma's needle free injection technology, INJEX 30, for import and sale into the US Market. The FDA had registered INJEX Pharma, Berlin, and INJEX Pharma US, Miami, and issued approval for the import and ...
Tags: pharmaceutical technology, INJEX Pharma, needle free injection system
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
The US FDA has approved Novo Nordisk Victoza (liraglutide [rDNA] injection) label to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin). Label update also includes approval of ...
Tags: Label update, type 2 diabetes, Victoza
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) for Pioglitazone tablets USP, 15mg, 30mg and 45mg. Previously, FDA has also approved the company's ANDA for Pioglitazone Hydrochloride and ...
Rising Pharmaceuticals will unveil the first generic version of the Ultramicrosize Griseofulvin tablets USP 25mg and 250mg strengths, which are an FDA approved generic version of PEDiNOL Pharmacal's Gris-PEG(R). Used to treat fungus ...
The US Federal Drug Administration (FDA) has received an application from Sobi for Kineret (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID). The filing is made under an Orphan Drug Designation for ...
Mylan Pharmaceuticals has introduced the generic version of Schering-Plough's Clarinex allergy medication, Desloratadine tablets, 5mg. Mylan gained final FDA approval for its abbreviated new drug application for Desloratadine Tablets, ...
Tags: Generic Clarinex Tablets, Desloratadine tablets, drug applications
Dr Reddy's Laboratories has introduced bioequivalent generic version of Plavix, Clopidogrel Tablets, USP 75mg and 300mg, in the US. The Clopidogrel Tablets USP, 75mg are available in bottle count sizes of 30, 90 and 500, and tablets of ...
Tags: Generic Version of Plavix, Clopidogrel Tablets, IMS Health