New Drug Application News and Research

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FDA grants Impax tentative approval of ANDA for FLOMAX generic version

Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX® for the functional symptoms of benign prostatic hyperplasia.

5 Oct 2009

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.

5 Oct 2009

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

GlaxoSmithKline and XenoPort, Inc. today announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher.

5 Oct 2009

sNDA for Clonicel submitted to the FDA

Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

2 Oct 2009

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

AFRESA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

2 Oct 2009

Orexigen's Empatic Phase 2b results demonstrate weight loss

Orexigen Therapeutics, Inc. today announced that its 24-week, Phase 2b trial for Empatic(TM) (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.

1 Oct 2009

Addrenex submits a sNDA to the FDA for Clonicel

Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

1 Oct 2009

Alexza enters into agreement with institutional investors to raise $19.7 million

Alexza Pharmaceuticals, Inc. announced today that it has entered into a definitive agreement with various institutional investors to raise $19.7 million in a private placement of its common stock.

1 Oct 2009

EMD Serono submits NDA for Cladribine Tablets in the U.S.

EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

1 Oct 2009

Amicus Therapeutics to initiate Phase 1 study of AT2220

Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease.

30 Sep 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

30 Sep 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

30 Sep 2009

ODT conference to discuss enforcement trends for supply chain compliance in the orthopedic industry

Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Nikki Willett, vice president of Marketing & Regulatory Affairs for Pilgrim, will address an audience of medical technology innovators at the ODT Conference & Exhibition 2009, October 7, in Fort Wayne, Indiana.

30 Sep 2009

AFRESA Inhalation Powder and AFRESA Inhaler NDA under FDA review

AFRESA® (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin able to more closely replicate normal glucose suppression than currently available insulins, according to data presented at the 45th Annual Meeting of the European Association for the Study of Diabetes.

30 Sep 2009

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

Australian company, Acrux, today announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

29 Sep 2009

Sciele Pharma files NDA for glycopyrrolate oral solution

Sciele Pharma, Inc., a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders.

29 Sep 2009

European Commission grants conditional marketing authorization for Gilead's Cayston

Gilead Sciences, Inc. announced today that the European Commission has granted conditional marketing authorization for Cayston® 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF) aged 18 years and older.

28 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

New Drug Application News and Research

FDA grants Impax tentative approval of ANDA for FLOMAX generic version

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

sNDA for Clonicel submitted to the FDA

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

Orexigen's Empatic Phase 2b results demonstrate weight loss

Addrenex submits a sNDA to the FDA for Clonicel

Alexza enters into agreement with institutional investors to raise $19.7 million

EMD Serono submits NDA for Cladribine Tablets in the U.S.

Amicus Therapeutics to initiate Phase 1 study of AT2220

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Orphan drug designation for pixantrone applied by Cell Therapeutics

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

ODT conference to discuss enforcement trends for supply chain compliance in the orthopedic industry

AFRESA Inhalation Powder and AFRESA Inhaler NDA under FDA review

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

Sciele Pharma files NDA for glycopyrrolate oral solution

European Commission grants conditional marketing authorization for Gilead's Cayston

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

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