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Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA).

4 Jan 2012

FDA sets Feb. 9 for ODAC meeting to review CTI's resubmitted pixantrone NDA

Cell Therapeutics, Inc. (CTI) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy.

3 Jan 2012

Mylan receives final FDA approval for Levetiracetam ER Tablets 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 Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg.

28 Dec 2011

Mylan receives final FDA approval for Eprosartan Mesylate 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 Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

28 Dec 2011

Perrigo receives final approval from FDA for Desloratadine ANDA

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Desloratadine tablets.

27 Dec 2011

Eisai resubmits NDA for perampanel to treat epilepsy-associated seizures

Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011.

26 Dec 2011

FDA accepts Gilead's Quad HIV regimen NDA for review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

26 Dec 2011

FDA EMDAC schedules to review VIVUS' Qnexa NDA for treatment of obesity

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012.

26 Dec 2011

Top-line results from Noven's LDMP Phase 3 clinical study on menopausal VMS

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from the first of two planned Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP, formerly referred to as Mesafem) for the treatment of vasomotor symptoms (VMS) associated with menopause.

23 Dec 2011

EpiCept receives FDA approval to commence AmiKet Phase III trial for CIPN

EpiCept Corporation today announced that at a meeting earlier this week with the U.S. Food and Drug Administration (FDA), the Company was granted permission to initiate immediately the Phase III clinical development of AmiKet.

23 Dec 2011

Impax submits IPX066 NDA to FDA for treatment of Parkinson's

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. today announced the submission of Impax's New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson's disease (PD). IPX066 is a patented extended release capsule formulation of carbidopa-levodopa.

22 Dec 2011

FDA accepts Pfizer's tofacitinib NDA for review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

21 Dec 2011

Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011

Eculizumab protects children from severe Shiga toxin-associated HUS

A physician and researcher at the Sainte Justine University Hospital Center (Sainte-Justine UHC), a University of Montreal affiliate, saved the life of a child and, by doing so, became the first to find a new use for a drug in the fight against deadly E. coli bacteria.

20 Dec 2011

Top-line results from AstraZeneca and Targacept's TC-5214 Phase 3 study on MDD

AstraZeneca and Targacept, Inc. today announced top-line results from the second of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment.

20 Dec 2011

Alkermes commences ALKS 9070 phase 3 clinical trial for schizophrenia

Alkermes plc today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system disorders.

19 Dec 2011