New Drug Application News and Research

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Watson Pharmaceuticals receives FDA approval for generic Combunox

Watson Pharmaceuticals, Inc. has announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride and Ibuprofen Tablets (CII) in the 5 mg/400 mg strength.

27 Nov 2007

BioMarin files investigational NDA for PEG-PAL for the treatment of phenylketonuria

BioMarin Pharmaceutical Inc. has announced that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase, for the treatment of phenylketonuria (PKU).

27 Nov 2007

GlaxoSmithKline obtains U.S. OTC marketing rights to MEVACOR (lovastatin) from Merck

GlaxoSmithKline, Philadelphia, PA, USA (GSK) and Merck & Co., Inc., Whitehouse Station, NJ, USA (Merck), announced today that they have entered into an agreement for over-the-counter (OTC) marketing rights for MEVACOR (lovastatin).

27 Nov 2007

FDA accepts Schering-Plough's new drug application for Asenapine

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet.

26 Nov 2007

Barr Pharmaceuticals confirms patent challenge of Focalin XR

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed for Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules, 5mg, 10mg, 15mg & 20mg. Focalin XR is manufactured for the U.S. for Novartis Pharmaceuticals Corporation by Elan Holdings Inc.

21 Nov 2007

Cethromycin achieves all endpoints in second pivotal Phase III Trial for treatment for pneumonia

Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced positive results from Trial CL-05, the second of two pivotal phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral antibiotic for the treatment of mild-to-moderate community acquired pneumonia (CAP), the sixth leading cause of death in the United States.

16 Nov 2007

Pfizer and Nektar resolve outstanding Exubera contractual issues

Pfizer and Nektar Therapeutics have announced that the two companies have resolved all outstanding contractual issues in connection with Exubera and Nektar's innovative Next Generation Inhaled Insulin (NGI) product currently in Phase 1 clinical development.

14 Nov 2007

New investigational combination pill improves multiple cholesterol disorders

Patients treated with a new investigational combination pill showed significant improvements in cholesterol, triglycerides and other key lipids that lead to heart disease, according to results presented at the American Heart Association's Scientific Sessions.

5 Nov 2007

Fabre Kramer Pharmaceuticals receives FDA decision on Gepirone ER for major depressive disorder

Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.

5 Nov 2007

Barr confirms patent challenge of Ritalin LA

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Novartis Pharmaceuticals Corporation in connection with its Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 10mg, 20mg, 30mg and 40mg.

5 Nov 2007

Safety of nebulized Formoterol in COPD

Data from two Phase III clinical trials were presented today in Chicago at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), supporting the use of Perforomist (formoterol fumarate) Inhalation Solution as a safe and effective maintenance treatment for COPD patients.

24 Oct 2007

Adenoscan patent lawsuits settled

Astellas Pharma Inc., King Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. have announced that U.S. subsidiaries of Astellas, along with Item Development AB and King have executed settlement agreements with one of Teva's subsidiaries on lawsuits filed in the United States against Teva's subsidiaries regarding their submission of an abbreviated new drug application (ANDA) for a generic version of Adenoscan (adenosine injection), a pharmacologic stress agent.

22 Oct 2007

$Accentia announces investigational new drug application for Revimmune for refractory MS$

Accentia announces investigational new drug application for Revimmune for refractory MS

Accentia Biopharmaceuticals has announced that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune.

10 Oct 2007

Mylan settles Levetiracetam patent case

Mylan Inc. has announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into an agreement to settle pending litigation with UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) relating to Levetiracetam Tablets, 250mg, 500mg and 750mg, the generic version of UCB's Keppra.

4 Oct 2007

Vanda Pharmaceuticals submits iloperidone NDA

Vanda Pharmaceuticals has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia.

27 Sep 2007

Watson Pharmaceuticals receives FDA approval for generic Accuneb

Watson Pharmaceuticals, Inc. has announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths.

27 Sep 2007

Barr confirms UROXATRAL patent challenge

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sanofi- Aventis U.S. LLC in connection with its UROXATRAL (alfuzosin hydrochloride extended-release tablets), 10mg.

25 Sep 2007

FDA fast tracks PI-88 for the treatment of post resection liver cancer

Progen Pharmaceuticals Limited has announced that its investigational anti-cancer drug PI-88 has been awarded Fast Track status by the U.S. Food and Drug Administration (FDA).

25 Sep 2007

FDA accepts Sucampo's sNDA for Lubiprostone for the treatment of irritable bowel syndrome

Sucampo Pharmaceuticals, Inc., has announced that the supplemental New Drug Application (sNDA) for lubiprostone (8 mcg, oral gel capsules, twice daily) for the treatment of irritable bowel syndrome with constipation (IBS-C) has been accepted for review by the U.S. Food and Drug Administration (FDA).

18 Sep 2007

Customized virus kills brain tumor stem cells that drive lethal cancer

A tailored virus destroys brain tumor stem cells that resist other therapies and cause lethal re-growth of cancer after surgery, a research team led by scientists at the University of Texas M. D. Anderson Cancer Center reports in the Sept. 18 edition of the Journal of the National Cancer Institute.

12 Sep 2007