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Celator Pharmaceuticals' CPX-351 receives FDA Fast Track designation for secondary AML treatment

Celator Pharmaceuticals' CPX-351 receives FDA Fast Track designation for secondary AML treatment

Celator Pharmaceuticals, Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that the U.S. Food and Drug Administration granted Fast Track designation for CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary Acute Myeloid Leukemia (AML). [More]
Using MDRS to accelerate deformulation: a new whitepaper from Malvern Instruments

Using MDRS to accelerate deformulation: a new whitepaper from Malvern Instruments

A new whitepaper from Malvern Instruments on Oral Solid Dose (OSD) deformulation demonstrates how the analytical technique of Morphologically Directed Raman Spectroscopy (MDRS) can be used to accelerate the development of generic products to a successful conclusion. [More]
Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the US Food and Drug Administration. [More]
LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis. [More]
FDA receives Actavis' NDA resubmission for cariprazine

FDA receives Actavis' NDA resubmission for cariprazine

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. [More]
Saatchi Bill: an interview with Dr. David Collingridge, Editor-in-Chief, The Lancet Oncology

Saatchi Bill: an interview with Dr. David Collingridge, Editor-in-Chief, The Lancet Oncology

The intention of the Medical Innovation Bill is to encourage and support doctors to explore new medicines for their patients when they believe existing options are no longer achieving good outcomes. [More]
Newron, Zambon announce re-submission of safinamide NDA to FDA

Newron, Zambon announce re-submission of safinamide NDA to FDA

Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its commercial and development partner Zambon S.p.A., an international pharmaceutical company, announced today that the NDA for safinamide has been re-submitted to the US FDA. [More]
LCS Therapeutics collaborates to commercialize patent on method to treat binge eating disorder

LCS Therapeutics collaborates to commercialize patent on method to treat binge eating disorder

LCS Therapeutics announced today that it has entered into a strategic collaboration with Lucerne Biosciences, LLC to commercialize U.S. Patent No. 8,318,813 entitled "Method of Treating Binge Eating Disorder." [More]
United Therapeutics submits pre-market approval application for use of Remodulin with implantable drug infusion system

United Therapeutics submits pre-market approval application for use of Remodulin with implantable drug infusion system

United Therapeutics Corporation (NASDAQ: UTHR) announced today that Medtronic, Inc. (NYSE: MDT) has submitted a pre-market approval application to the U.S. Food and Drug Administration (FDA) for the use of Medtronic's SynchroMed® II implantable drug infusion system (including a newly developed catheter) for use with United Therapeutics' Remodulin® (treprostinil) Injection delivered intravenously to patients with pulmonary arterial hypertension. [More]
FDA approves Novo Nordisk’s weight loss injection, Saxenda

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management. [More]
Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

Actavis plc today confirmed that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for the fixed-dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension. [More]
FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. [More]
PTC begins rolling NDA submission for Translarna to treat nmDMD

PTC begins rolling NDA submission for Translarna to treat nmDMD

PTC Therapeutics, Inc. today announced that it has commenced a rolling submission of a New Drug Application to the United States Food and Drug Administration for Translarna™ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). [More]
Mylan announces U.S. launch of Prednisolone Sodium Phosphate Orally Disintegrating Tablets

Mylan announces U.S. launch of Prednisolone Sodium Phosphate Orally Disintegrating Tablets

Mylan Inc. today announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. [More]

Mylan introduces Methocarbamol Injection USP, 100 mg/mL in the U.S.

Mylan Inc. today announced the U.S. launch of its Methocarbamol Injection USP, 100 mg/mL, packaged in 1,000 mg/10 mL single-dose vials. This product is the generic version of Hikma Maple Ltd.'s Robaxin. [More]
Daiichi Sankyo releases new formulation of LIXIANA 60 mg Tablets

Daiichi Sankyo releases new formulation of LIXIANA 60 mg Tablets

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has launched a new formulation of LIXIANA 60 mg Tablets (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban, approval to market: September 26, 2014; NHI drug price listing: November 25, 2014) in Japan for the recently approved indications: the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)]. [More]

New report examines how companies educate employees, prepare for new product launch

When a pharmaceutical company is gearing up for a new product launch, effective brand and communications leaders focus not only on external communications but also internal disease state communication and education directed at employees. [More]
FDA Advisory Committee votes in favor of Actavis' ceftazidime-avibactam

FDA Advisory Committee votes in favor of Actavis' ceftazidime-avibactam

Actavis plc today announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application (NDA) for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) (including acute pyelonephritis) caused by Gram-negative pathogens. [More]
PulmoFlow's nebulized drug and device combination gets FDA approval for cystic fibrosis

PulmoFlow's nebulized drug and device combination gets FDA approval for cystic fibrosis

On Tuesday, the FDA granted final approval of PulmoFlow, Inc.'s New Drug Application for Kitabis Pak – a co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS Nebulizer. This is the first nebulized drug and device combination to be approved for patients with cystic fibrosis. [More]
Perrigo receives final FDA approval for diclofenac sodium topical solution 1.5% w/w

Perrigo receives final FDA approval for diclofenac sodium topical solution 1.5% w/w

Perrigo Company plc today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for diclofenac sodium topical solution 1.5% w/w. Shipments to our pharmacy customers have commenced. [More]