New Drug Application News and Research

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SCLR announces FDA's issue of deficiency letter for pseudoephedrine ANDA

SCOLR Pharma, Inc. today announced it has received a letter from the Food and Drug Administration identifying deficiencies regarding its Abbreviated New Drug Application for extended-release pseudoephedrine.

14 Mar 2011

Arena fourth quarter net loss decreases to $28.2 million

Arena Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2010, and reviewed recent developments.

11 Mar 2011

FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

CTI announces final pixantrone clinical trial design for treatment of DLBCL

Cell Therapeutics, Inc. today announced the final clinical trial design of a randomized pivotal trial of pixantrone for the treatment of diffuse large B-cell lymphoma following discussions with the U.S. Food and Drug Administration's Division of Hematologic Products.

10 Mar 2011

FDA accepts Merck's SAFLUTAN NDA for standard review

Merck, known as MSD outside the United States and Canada, announced today that the New Drug Application for SAFLUTAN, Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, has been accepted for standard review by the U.S. Food and Drug Administration.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

FDA removes clinical hold for Amicus' AT2220 IND for treatment of Pompe disease

Amicus Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the AT2220 (1-deoxynojirimycin HCI) Investigational New Drug Application (IND). AT2220 is a pharmacological chaperone in development as a treatment for Pompe disease.

9 Mar 2011

FDA accepts BMY and AstraZeneca's dapagliflozin NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has accepted for review a New Drug Application for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus.

9 Mar 2011

Alliqua completes transdermal pain patch initial in vitro study for treatment of PHN

Alliqua, Inc., an advanced biomedical products company focused on the development and manufacturing of proprietary drug delivery and liver health technologies, announced today the successful completion of its initial in vitro permeation study for its transdermal pain patch project.

8 Mar 2011

FDA accepts Lundbeck's clobazam NDA for review

Lundbeck Inc. today announced the U.S. Food and Drug Administration has accepted for review a New Drug Application for the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome in patients two years and older.

5 Mar 2011

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II hereditary angioedema (HAE) attacks licensed for self-administration in Europe.

4 Mar 2011

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.

3 Mar 2011

CTI meets officials of FDA's OND to support pixantrone NDA

Cell Therapeutics, Inc. today announced that it has met with officials of the FDA's Office of New Drugs in Maryland and presented its arguments supporting the Company's belief that the data contained in its New Drug Application 22-481 support the conclusion that pixantrone is effective for its planned use.

3 Mar 2011

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

EpiCept Corporation today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia patients in its previous Phase III trial with Ceplene administered with low-dose interleukin-2.

3 Mar 2011

FDA accepts Handa's generic DEXILANT ANDA for review

Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration.

2 Mar 2011

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

GTx, Inc. today announced that the company and Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.

2 Mar 2011

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

The Institute for OneWorld Health (iOWH) announced a major milestone in the fight against cholera. The Food and Drug Administration (FDA) granted iOWH permission to begin phase 1 trials for iOWH032, a drug to treat secretory diarrhea. This is the first submission of an Investigational New Drug application for a completely new chemical entity by a non-profit of this size to receive such rapid FDA clearance, and it could be the first synthetic drug of its kind for diarrheal diseases.

2 Mar 2011

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

New Drug Application News and Research

SCLR announces FDA's issue of deficiency letter for pseudoephedrine ANDA

Arena fourth quarter net loss decreases to $28.2 million

FDA approves Matrix NDA for Zidovudine Tablets

CTI announces final pixantrone clinical trial design for treatment of DLBCL

FDA accepts Merck's SAFLUTAN NDA for standard review

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

FDA removes clinical hold for Amicus' AT2220 IND for treatment of Pompe disease

FDA accepts BMY and AstraZeneca's dapagliflozin NDA for review

Alliqua completes transdermal pain patch initial in vitro study for treatment of PHN

FDA accepts Lundbeck's clobazam NDA for review

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

CTI meets officials of FDA's OND to support pixantrone NDA

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

FDA accepts Handa's generic DEXILANT ANDA for review

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

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