New Drug Application News and Research

RSS

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.

29 Dec 2014

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."

26 Dec 2014

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.

25 Dec 2014

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.

25 Dec 2014

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.

25 Dec 2014

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.

25 Dec 2014

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).

23 Dec 2014

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.

11 Dec 2014

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.

11 Dec 2014

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)].

8 Dec 2014

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.

7 Dec 2014

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.

5 Dec 2014

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.

3 Dec 2014

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.

2 Dec 2014

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics, Inc.today announced the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency.

1 Dec 2014

FDA issues Complete Response letter for Avanir’s AVP-825 NDA

Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for AVP-825.

27 Nov 2014

Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

PharmaMar announces that Janssen Research & Development, LLC has submitted a New Drug Application (NDA) for YONDELIS (trabectedin) to the U.S. Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

26 Nov 2014

PPMD, Santhera Pharmaceuticals collaborate to study Duchenne muscular dystrophy

Parent Project Muscular Dystrophy, the leading advocacy organization working to end Duchenne muscular dystrophy (Duchenne) and Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focusing on the development and marketing of innovative pharmaceutical products for the treatment of mitochondrial and neuromuscular diseases, will collaborate on a benefit/risk study in Duchenne.

25 Nov 2014

Isis Pharmaceuticals announces initiation of ISIS-SMN Rx Phase 3 study in children with SMA

Isis Pharmaceuticals, Inc. announced today the initiation of a pivotal Phase 3 study evaluating ISIS-SMNRx in approximately 120 non-ambulatory children with spinal muscular atrophy (SMA).

25 Nov 2014

Janssen announces submission of NDA for three-month paliperidone palmitate

Janssen Research & Development, LLC today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration. The NDA seeks approval for the medication as a treatment for schizophrenia in adults.

19 Nov 2014

New Drug Application News and Research

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

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

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

FDA approves Novo Nordisk’s weight loss injection, Saxenda

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

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

PTC begins rolling NDA submission for Translarna to treat nmDMD

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

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

Daiichi Sankyo releases new formulation of LIXIANA 60 mg Tablets

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

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

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

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

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

FDA issues Complete Response letter for Avanir’s AVP-825 NDA

Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

PPMD, Santhera Pharmaceuticals collaborate to study Duchenne muscular dystrophy

Isis Pharmaceuticals announces initiation of ISIS-SMN Rx Phase 3 study in children with SMA

Janssen announces submission of NDA for three-month paliperidone palmitate

Drug Discovery - Second Edition eBook

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Latest News