New Drug Application News and Research

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Lubiprostone may improve symptom relief rates in adults with irritable bowel syndrome

A new study demonstrated that the active ingredient in AMITIZA (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C).

22 May 2007

Lupin Pharmaceuticals receives FDA approval for Simvastatin tablets

Lupin Pharmaceuticals, Inc. has announced that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.

16 May 2007

FDA approves Dey, L.P.'s NDA for chronic obstructive pulmonary disease inhalation solution

Dey, L.P. has announced that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

15 May 2007

BEMA Fentanyl demonstrates substantial transmucosal delivery

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the results of a 12 subject, crossover study comparing the absorption of fentanyl from both single and multiple BEMA? Fentanyl discs, as well as oral and intravenous doses of fentanyl.

8 May 2007

Spherix starts phase 3 clinical trial of treatment for type 2 diabetes

Spherix Incorporated has announced that it has begun its Phase 3 clinical trial of Naturlose as a treatment for Type 2 diabetes.

2 May 2007

FDA advisory committee supports Advair 500/50 in reducing COPD exacerbations

An Advisory Committee to the Food and Drug Administration (FDA) has unanimously agreed that GlaxoSmithKline's Advair Diskus 500/50 (fluticasone propionate and salmeterol inhalation powder) demonstrated a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S.

2 May 2007

Submission of NDA for Istradefylline(KW-6002), an investigational anti-Parkinson's disease drug

Kyowa Hakko Kogyo Co. has announced that Kyowa Pharmaceutical, Inc., its wholly owned U.S subsidiary, submitted on April 25, 2007 a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinson's disease.

30 Apr 2007

Caraco Pharmaceuticals to market generic Nimotop

Caraco Pharmaceutical Laboratories has announced that it will market Nimodipine Capsules, 30mg (Nimotop) on behalf of Sun Pharmaceutical Industries, Inc. (Sun), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd.

30 Apr 2007

Novagali Pharma announces FDA clearance of trial for treatment of dry eye syndrome

Novagali Pharma has announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its Cyclosporine A ocular product, Nova22007, has been granted by the U.S. Food and Drug Administration (FDA).

27 Apr 2007

Wyeth Pharmaceuticals receives FDA approvable for Bazedoxifene for the prevention of postmenopausal osteoporosis

Wyeth Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.

26 Apr 2007

Abbott submits NDA for combination Niaspan/Simvastatin tablet

Abbott has submitted a New Drug Application to the Food and Drug Administration for a fixed-dose combination (Simcor) of Niaspan (extended-release niacin) and simvastatin.

24 Apr 2007

Pharmacyclics announces NDA for Xcytrin injection

Pharmacyclics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has filed the company's New Drug Application (NDA) for Xcytrin (motexafin gadolinium) Injection.

24 Apr 2007

Mylan anounces FDA approval of Zolpidem Tartrate tablets

Mylan Laboratories has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets, 5 mg and 10 mg.

24 Apr 2007

Indevus Pharmaceuticals submits supplemental NDA for VALSTAR

Indevus Pharmaceuticals has announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to reintroduce VALSTAR in the United States.

20 Apr 2007

Anadys Pharmaceuticals presents data showing ANA773 promotes anti-tumor activity of killer cells

Anadys Pharmaceuticals presented data from an in vitro study showing that the active metabolite of ANA773 promotes natural killer (NK) cell-mediated anti-tumor response by inducing cytokine secretion, cytolysis of tumor cells and enhanced antibody-dependent cellular cytotoxicity (ADCC), during a poster presentation at the Annual Meeting of the American Association of Cancer Research (AACR) in Los Angeles.

18 Apr 2007

Genzyme completes study on Sevelamer Carbonate in patients with chronic kidney disease

Genzyme has announced that a recently completed study of Renvela (sevelamer carbonate) achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for hyperphosphatemic patients with chronic kidney disease who are not on dialysis.

17 Apr 2007

FDA accepts Satraplatin NDA for priority review

Spectrum Pharmaceuticals has announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the U.S. Food & Drug Administration (FDA).

17 Apr 2007

FDA accepts GPC Biotech's Satraplatin NDA

GPC Biotech AG has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed.

17 Apr 2007

Mylan announces FDA approval for Glipizide and Metformin Hydrochloride tablets

Mylan Laboratories has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Glipizide and Metformin Hydrochloride Tablets in 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths.

14 Apr 2007

Novalar Pharmaceuticals submits NDA for dental anesthetic reversal agent

Novalar Pharmaceuticals, Inc. today announced the submission of a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) for marketing approval of NV-101, a local dental anesthetic reversal agent.

11 Apr 2007