New Drug Application News and Research

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USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

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 Orion's Stalevo® tablets.

1 Oct 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

30 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

Senesco fiscal 2010 revenue decreases to $140,000

Senesco Technologies, Inc. reported financial results for the 12 months ended June 30, 2010 ("Fiscal 2010").

29 Sep 2010

Tamir's compounds perform better than Ganciclovir for Cytomegalovirus disease: Study

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds outperformed market leader Roche's drug Ganciclovir in cell culture and plaque reduction assay (the gold standard) for Cytomegalovirus (CMV) disease. Additionally, antiviral activity was also apparent against other human herpesviruses, namely, HSV-1 (cold sores), HSV-2 (genital herpes), and Varicella-Zoster Virus (VZV) (chicken-pox and shingles).

29 Sep 2010

FDA issues warning letters to three companies for claiming plaque removal by mouth rinse products

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

29 Sep 2010

USFDA approves Sun Pharmaceutical's ANDA to market Rilutek tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sanofi Aventis's Rilutek® tablets 50 mg.

29 Sep 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

Perrigo files NDA with FDA for generic Zegerid OTC

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC™, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.

24 Sep 2010

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

Yaupon Therapeutics, a privately held specialty pharmaceutical company, today announced positive top-line results from the pivotal multi-center study of its lead product candidate, a proprietary topical mechlorethamine gel for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages I-IIa). The top-line data show that the study, which was conducted under a Special Protocol Assessment (SPA), achieved its primary and secondary endpoints.

24 Sep 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

23 Sep 2010

FDA grants priority review status for Endo’s oxymorphone oral formulation

Endo Pharmaceuticals announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status.

23 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

FDA approves Mylan's generic Prograf Capsules ANDA

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 Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

21 Sep 2010

VIVUS announces QNEXA study results for obesity treatment

VIVUS, Inc. today announced positive top-line results from a two-year study of QNEXA(phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.

21 Sep 2010

Chelsea Therapeutics' Phase III NORTHERA Study 301 meets primary endpoint

Chelsea Therapeutics International, Ltd. announced that preliminary analyses of its Phase III NORTHERA™ Study 301 met its primary endpoint. Treatment with Northera provided clinically meaningful and statistically significant improvement.

20 Sep 2010

CMB initiates first human trial for plant-produced H1N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today it has initiated the first human trial of plant-produced H1N1 influenza vaccine at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC).

18 Sep 2010

New Drug Application News and Research

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Senesco fiscal 2010 revenue decreases to $140,000

Tamir's compounds perform better than Ganciclovir for Cytomegalovirus disease: Study

FDA issues warning letters to three companies for claiming plaque removal by mouth rinse products

USFDA approves Sun Pharmaceutical's ANDA to market Rilutek tablets

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Perrigo files NDA with FDA for generic Zegerid OTC

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

FDA grants priority review status for Endo’s oxymorphone oral formulation

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

FDA approves Mylan's generic Prograf Capsules ANDA

VIVUS announces QNEXA study results for obesity treatment

Chelsea Therapeutics' Phase III NORTHERA Study 301 meets primary endpoint

CMB initiates first human trial for plant-produced H1N1 influenza vaccine

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