FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension
Forest Laboratories, Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic(TM)), a novel beta blocker under review for the treatment of hypertension.
Read more ...
Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension
Forest Laboratories, Inc. (NYSE: FRX) today announced the results of a double-blind, randomized, placebo-controlled clinical trial, published in the November 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol significantly reduced sitting diastolic and systolic blood pressure used as monotherapy among African-American patients with stage I-II hypertension.
Read more ...
Teva Announces Approval of Generic Actonel®
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg.
Read more ...
FDA Accepts sNDA for Expanded Use of Angiomax®
The Medicines Company (NASDAQ: MDCO) announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax® (bivalirudin) for the treatment of acute coronary syndromes (ACS), specifically in patients with unstable angina or non-segment elevation myocardial infarction (NSTEMI).
Read more ...
Protherics licenses its Covaccine HT adjuvant to Nobilon for influenza vaccine indications
Protherics PLC, the international biopharmaceutical company focused on critical care and cancer, and Nobilon International B.V., part of Organon, the human health care business unit of Akzo Nobel, today announced that Nobilon has licensed Protherics' CoVaccine HT™ adjuvant for use in pandemic influenza vaccines and seasonal influenza vaccines in elderly people.
Read more ...
Invega® receives marketing authorisation in European Union for treatment of schizophrenia
The European Commission, on 25 June 2007, granted marketing authorisation for INVEGA® (paliperidone prolonged-release tablets), a new atypical antipsychotic medication for the treatment of schizophrenia. This once daily medication is specifically designed to deliver paliperidone - the active ingredient in INVEGA® - through the innovative osmotic delivery system (OROS®) resulting in strong efficacy, a proven safety and tolerability profile and improved patient functioning.
Read more ...
FDA Accepts NDA Filing for Cleviprex(TM) for the Treatment of Acute Hypertension
The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's new drug application (NDA) for Cleviprex(TM) (clevidipine butyrate injectable emulsion) for the treatment of acute hypertension. If approved, Cleviprex will be the first new treatment for acute hypertension in more than 10 years.
Read more ...
Forest Laboratories, Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic(TM)), a novel beta blocker under review for the treatment of hypertension. 
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg. 
The Medicines Company (NASDAQ: MDCO) announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax® (bivalirudin) for the treatment of acute coronary syndromes (ACS), specifically in patients with unstable angina or non-segment elevation myocardial infarction (NSTEMI). 
Protherics PLC, the international biopharmaceutical company focused on critical care and cancer, and Nobilon International B.V., part of Organon, the human health care business unit of Akzo Nobel, today announced that Nobilon has licensed Protherics' CoVaccine HT™ adjuvant for use in pandemic influenza vaccines and seasonal influenza vaccines in elderly people. 
The European Commission, on 25 June 2007, granted marketing authorisation for INVEGA® (paliperidone prolonged-release tablets), a new atypical antipsychotic medication for the treatment of schizophrenia. This once daily medication is specifically designed to deliver paliperidone - the active ingredient in INVEGA® - through the innovative osmotic delivery system (OROS®) resulting in strong efficacy, a proven safety and tolerability profile and improved patient functioning.