New Drug Application News and Research

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Spherix starts patient recruitment in India for phase 3 diabetes trial

Spherix Incorporated reported that patient recruitment for its Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose, has begun in India. Expectations for India are to provide more than 300 patients spread across 35 sites for the pivotal Phase 3 trial.

8 Nov 2008

FDA approves Ranexa for the treatment of chronic angina

CV Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina.

7 Nov 2008

Mylan receives final approval for generic version of antiepileptic Keppra

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra.

4 Nov 2008

FDA warns Bayer HealthCare on over-the-counter aspirin product

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

28 Oct 2008

Targanta Therapeutics presents preclinical data on Oritavancin against Clostridium difficile infection

Targanta Therapeutics Corporation has released the in vivo data from a preclinical study comparing the activity of its antibiotic drug candidate, oritavancin, to vancomycin in a hamster model of Clostridium difficile infection.

26 Oct 2008

Mylan confirms generic Lescol patent challenge

Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

22 Oct 2008

Mylan receives tentative FDA approval for generic versions of Benicar and Uroxatral

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

22 Oct 2008

Barr Laboratories confirms Opana ER tablet patent challenge

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

22 Oct 2008

Teva granted FDA approval for Fentanyl transdermal system

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.

20 Oct 2008

FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

Advanced Life Sciences submits NDA for cethromycin in mild-to-moderate community acquired pneumonia

Advanced Life Sciences Holdings, Inc. has announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

2 Oct 2008

Exelixis files investigational new drug application for anticancer compound

Exelixis, Inc. announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL888, a novel anticancer compound. XL888 is an orally available small molecule inhibitor of HSP90, which is a chaperone protein that promotes the activity and stability of a range of key regulatory proteins, including kinases.

2 Oct 2008

Plethora Solutions completes European trial of PSD502 for premature ejaculation

Sciele Pharma, Inc. today announced that Plethora Solutions Holdings PLC has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

30 Sep 2008

Arana files U.S. IND for lead anti-Inflammatory

Biotechnology company Arana Therapeutics Limited today announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication.

29 Sep 2008

Arana updates inflammatory pipeline milestones

Biotechnology company Arana Therapeutics Limited today provided an update on the major inflammatory compounds in its drug development pipeline. As part of this update, Arana said it has developed a new antibody candidate ART123, targeting inflammatory diseases and it plans to start a Phase I clinical trial for age-related macular degeneration (AMD) candidate PMX53 in 2009.

21 Sep 2008

GlaxoSmithKline and XenoPort submit NDA for Solzira for restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

16 Sep 2008

Mylan receives FDA approval for generic version of Risperdal

Mylan Inc today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

16 Sep 2008

Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug application (NDA) and the European marketing authorization application (MAA).

9 Sep 2008

Salix commences patent infringement litigation against Novel Laboratories

Salix Pharmaceuticals, Ltd. has announced that Salix Pharmaceuticals, Inc. has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of the patent protecting OSMOPREP (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets.

8 Sep 2008

Biovail files abbreviated new drug application for Fenofibrate tablets

Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

3 Sep 2008