New Drug Application News and Research

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Mylan Pharmaceuticals' ANDA for generic Wellbutrin SR receives FDA final approval

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 Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR®.

12 Apr 2010

FDA approves Mylan Pharmaceuticals' ANDA for generic Hyzaar

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 Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets 100 mg/12.5 mg, the generic version of Merck and Co., Inc.'s antihypertensive Hyzaar®.

12 Apr 2010

FDA approves Sinapis Pharma's IND for IV methamphetamine in treatment of acute stroke

Sinapis Pharma is pleased to announce that it has received notice from the FDA that its Investigational New Drug application (IND) for the use of IV methamphetamine for acute stroke was approved on April 9, 2010. "We have accomplished a great deal of work for a small company on a very tight budget. We have GMP drug ready for the Phase I clinical trial and the Phase I site is prepared to begin this protocol," said Dr. Donald Picker , the company CEO.

12 Apr 2010

Rib-X Pharmaceuticals to present delafloxacin Phase 2 study data at 20th ECCMID

Rib-X Pharmaceuticals, Inc., a development-stage antibiotics company with a broad product pipeline based on its innovative discovery platform, today announced that an oral presentation of data for delafloxacin, its lead antibiotic candidate, will be given at the 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 10-14, in Vienna, Austria by Paul G. Ambrose, Pharm.D, FIDSA, Director, Institute for Clinical Pharmacodynamics, Ordway Research Institute.

12 Apr 2010

Results of Phase I ThermoDox dose escalation trial to be discussed in a press conference

Celsion Corporation today announced that Dr. Ronnie T.P. Poon from the University of Hong Kong and lead principal investigator for the Asia Pacific region of the Phase I ThermoDox dose escalation trial will hold a press conference on Thursday, April 15, 2010 at 10:30 AM HKT (Wednesday, April 14, 2010 10:30 PM ET) to discuss the long-term follow-up of patients treated from April 2006 to December 2006.

12 Apr 2010

Sun Pharmaceutical Industries' generic Namenda ANDA: USFDA grants tentative approval

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets.

12 Apr 2010

FDA issues complete response letter regarding the NDA for OMAPRO

ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's Office of Oncology Drug Products has issued a complete response letter regarding the new drug application for OMAPRO for the treatment of adults with chronic myeloid leukemia who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

12 Apr 2010

Investment report on Somaxon Pharmaceuticals

StockPreacher.com announces an investment report featuring Somaxon Pharmaceuticals, Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

9 Apr 2010

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

Keryx Biopharmaceuticals, Inc. announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.

9 Apr 2010

Cell Therapeutics receives FDA Complete Response Letter for Pixuvri NDA

Cell Therapeutics, Inc. today announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Pixuvri™ (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").

9 Apr 2010

ZIOPHARM Oncology commences Phase I/II study of Zybulin for metastatic breast cancer

ZIOPHARM Oncology, Inc., announced today it has initiated a Phase I/II study at Memorial Sloan-Kettering Cancer Center for the novel, mathematically - determined administration of oral indibulin (Zybulin™ or ZIO-301) in the treatment of metastatic breast cancer.

9 Apr 2010

Phase 1 SAD study of PSI-938 for HCV initiated

Pharmasset, Inc. announced today that dosing has initiated in a phase 1, single ascending dose study in healthy volunteers with PSI-938, a third generation purine nucleotide analog polymerase inhibitor of hepatitis C virus. Pharmasset recently filed an Investigational New Drug Application with the Food and Drug Administration.

8 Apr 2010

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

In a clinical trial known as PROVE 3 published in this week's New England Journal of Medicine, treatment with telaprevir-based regimens significantly increased rates of sustained viral response (SVR) in patients with genotype 1 hepatitis C virus (HCV) infection who did not achieve SVR with at least one prior course of pegylated-interferon and ribavirin therapy.

8 Apr 2010

FDA approves Mylan Pharmaceuticals' generic NuLytely laxative

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 Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (with Flavor Packs), the generic version of Braintree Laboratories' NuLytely® laxative.

8 Apr 2010

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

MAP Pharmaceuticals, Inc. today announced that the Company initiated a pharmacodynamics (PD) trial to compare the acute effect of LEVADEX™ orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography.

8 Apr 2010

USFDA approves Sun Pharmaceutical Industries' ANDA for generic Wellbutrin SR Extended Release tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

8 Apr 2010

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Genta Incorporated today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

7 Apr 2010

IGRAs effective for detecting confirmed active TB disease: CHEST

New data from a meta-analysis of existing literature published today in CHEST, the official journal of the American College of Chest Physicians, demonstrate that Interferon Gamma Release Assays are superior to the previous standard in diagnostics, the 100+-year-old tuberculin skin test, for detecting confirmed active Tuberculosis disease.

7 Apr 2010

Accumetrics completes enrollment phase of GRAVITAS clinical trial

Accumetrics, Inc., a privately-held developer and marketer of the VerifyNow® System, the first rapid and easy to use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced that it has completed the enrollment phase of its landmark clinical trial, GRAVITAS.

7 Apr 2010

U.S. Court finds Teva Pharmaceutical Industries' Seasonique patent valid and enforceable

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Nevada has granted Teva's Motion for Summary Judgment with respect to the validity of U.S. Patent No. 7,320,969. In March 2008, Duramed, now Teva Women's Health, brought suit in the District of Nevada against Watson alleging infringement of Teva's patent as a result of Watson's filing of an Abbreviated New Drug Application (ANDA) for Seasonique®.

2 Apr 2010

New Drug Application News and Research

Mylan Pharmaceuticals' ANDA for generic Wellbutrin SR receives FDA final approval

FDA approves Mylan Pharmaceuticals' ANDA for generic Hyzaar

FDA approves Sinapis Pharma's IND for IV methamphetamine in treatment of acute stroke

Rib-X Pharmaceuticals to present delafloxacin Phase 2 study data at 20th ECCMID

Results of Phase I ThermoDox dose escalation trial to be discussed in a press conference

Sun Pharmaceutical Industries' generic Namenda ANDA: USFDA grants tentative approval

FDA issues complete response letter regarding the NDA for OMAPRO

Investment report on Somaxon Pharmaceuticals

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

Cell Therapeutics receives FDA Complete Response Letter for Pixuvri NDA

ZIOPHARM Oncology commences Phase I/II study of Zybulin for metastatic breast cancer

Phase 1 SAD study of PSI-938 for HCV initiated

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

FDA approves Mylan Pharmaceuticals' generic NuLytely laxative

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

USFDA approves Sun Pharmaceutical Industries' ANDA for generic Wellbutrin SR Extended Release tablets

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

IGRAs effective for detecting confirmed active TB disease: CHEST

Accumetrics completes enrollment phase of GRAVITAS clinical trial

U.S. Court finds Teva Pharmaceutical Industries' Seasonique patent valid and enforceable

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