Latest Pharmaceutical News
Glenmark Generics, Konec Receive Order From FDA To Stop Marketing Unapproved Nitroglycerin Tablets
FDA has ordered Glenmark Generics and Konec of Tucson, Ariz, to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3mg, 0.4mg, and 0.6mg dosages.
Published: 17-Mar-2010
Savient Pharma Refiles Biologics License Application For Krystexxa
Savient Pharma has resubmitted its biologics license application (BLA) to FDA for Krystexxa (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.
Published: 16-Mar-2010
Eli Lilly, Amylin Pharma, Alkermes Receive Complete Response Letter For Bydureon
Eli Lilly, Amylin Pharma and Alkermes have received complete response letter from FDA regarding the new drug application (NDA) for Bydureon (exenatide for extended-release injectable suspension).
Published: 15-Mar-2010
GSK Receives Marketing Authorisation For Revolade
GlaxoSmithKline (GSK) has received marketing authorisation from European Commission (EC) for its Revolade (eltrombopag), used in the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Published: 15-Mar-2010
MorphoSys Gets Japanese Patent For Core Antibody Technology HuCAL
MorphoSys has received a new patent from Japanese Patent Office for its core antibody technology HuCAL, which is processed and transmitted by Hugin.
Published: 15-Mar-2010
Ranbaxy, Takeda Pharma Settle Actos Patent Litigation
Ranbaxy Laboratories, with its wholly owned subsidiary Ranbaxy Pharmaceuticals (RPI), has reached an agreement with Takeda Pharma Company and Takeda Pharmaceuticals North America, to settle pending patent litigation regarding generic equivalent version of Actos (Pioglitazone Hydrochloride) 15mg, 30 mg and 45 mg tablets of Ranbaxy.
Published: 15-Mar-2010
Sanofi-aventis, Bristol-Myers Squibb Update On Plavix US Prescribing Information
Sanofi-aventis US and Bristol-Myers Squibb have come out with revisions to the US prescribing information for Plavix (clopidogrel bisulfate), which include a boxed warning, which concerns the diminished effectiveness of Plavix in patients who have a genetic variation causing reduced formation of the active metabolite.
Published: 12-Mar-2010
Abbott Seeks FDA Approval For Lupron Depot 45-mg Six Month Formulation
Abott has reported that the FDA has accepted review of the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer.
Published: 12-Mar-2010
FDA Gives Nod To Five-Day Dosing Regimen Of Dacogen To Treat MDS Patients
Eisai, a US-based pharma company, has received approval from US FDA for a five-day dosing regimen for Dacogen (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.
Published: 11-Mar-2010
NeoPharm Files ODA For IL13-PE38QQR
NeoPharm has filed an orphan drug application (ODA) with the Office of Orphan Products Development of the FDA to have orphan drug designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Published: 11-Mar-2010
