New Drug Application News and Research

RSS

FDA extends action date for inhaled Treprostinil (Tyvaso) NDA by three months

United Therapeutics Corporation has announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Tyvaso (inhaled treprostinil).

30 Apr 2009

Vion Pharmaceuticals' NDA for Onrigin accepted for FDA review

Vion Pharmaceuticals, Inc. has announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin (laromustine) Injection has been accepted for review by the U.S. Food and Drug Administration (FDA).

16 Apr 2009

Mylan confirms first-to-file patent challenge relating to Xeloda

Mylan Inc. has confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda Tablets, a chemotherapy treatment for breast and colorectal cancer.

14 Apr 2009

Mylan settles Clarinex patent case

Mylan Inc. has announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex allergy medication.

9 Apr 2009

Merck & Co and Cardiome sign agreement for Vernakalant

Merck & Co., Inc. and Cardiome Pharma Corp. has announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.

9 Apr 2009

Cancer vaccines receive orphan drug designation for advanced head and neck cancer

Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official.

9 Apr 2009

Coartem tablets approved in U.S. to treat malaria

The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

8 Apr 2009

Gilead Sciences announces notification of ANDA filing for Atripla

Gilead Sciences, Inc. has announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.

6 Apr 2009

Taro receives final FDA approval for Carbamazepine extended-release tablets

Taro Pharmaceutical Industries Ltd. has reported that it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application ("ANDA") for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg ("carbamazepine extended-release tablets").

6 Apr 2009

Teva receives approval for generic Yaz (Drospirenone and Ethinyl Estradiol) tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz® (Drospirenone and Ethinyl Estradiol) Tablets.

1 Apr 2009

District Court decision received in Concerta patent sase

The U.S. District Court for the District of Delaware has rendered a decision in the patent litigation between Alza Corporation, McNeil-PPC, Inc. and Andrx Pharmaceuticals LLC. McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which markets Concerta (methylphenidate HCI) Extended-Release Tablets CII, said the court held that the patent in suit is not valid or infringed by the filing of Andrx's Abbreviated New Drug Application.

1 Apr 2009

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

30 Mar 2009

ARCA biopharma presents data from phase 3 BEST trial of Gencaro

ARCA biopharma, Inc. has announced that data from the pivotal Phase 3 BEST trial of Gencaro (bucindolol hydrochloride) in patients with advanced chronic heart failure (CHF) was presented at the American College of Cardiology 58 th Annual Scientific Session being held March 29-31, 2009 in Orlando, Florida.

29 Mar 2009

Data suggesting that omacetaxine can eradicate leukemic stem cells may offer a breakthrough for CML

Data showing the ability of omacetaxine to kill leukemic stem cells in mouse models with drug-resistant chronic myelogenous leukemia (CML) are the subject of an advance online publication in the journal Leukemia, ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) announced today.

29 Mar 2009

Cubist Pharmaceuticals files patent infringement case against Teva Parenteral Medicines

Cubist Pharmaceuticals, Inc. has confirmed that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

23 Mar 2009

Warner Chilcott files new lawsuit for infringement of DORYX patent

Warner Chilcott Limited has announced hat one of its subsidiaries and Mayne Pharma International Pty. Ltd. ("Mayne") have filed a second lawsuit against Impax Laboratories, Inc. ("Impax") in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

20 Mar 2009

Sirion Therapeutics sNDA for Durezol to treat uveitis accepted for FDA review

Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% to treat endogenous anterior uveitis has been accepted for review.

16 Mar 2009

MannKind Corporation submits NDA for Afresa for treatment of diabetes

MannKind Corporation has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Afresa (insulin monomer human [rDNA origin]) Inhalation Powder and the Afresa Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.

16 Mar 2009

Pharmaxis announces NDA filing for Aridol

Pharmaxis, Inc., a wholly owned subsidiary of Pharmaxis Ltd , an emerging respiratory specialty pharmaceutical company, announced today that it has filed a New Drug Application (NDA), electronically, with the U.S. Food and Drug Administration (FDA) for Aridol (mannitol bronchial challenge test).

3 Mar 2009

Experimental drug fampridine improves mobility for some MS patients

In MS, the body's immune system attacks myelin, a fatty tissue that wraps and insultates nerve fibers, disrupting the transmission of signals in the central nervous system.

1 Mar 2009