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

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. [More]
FDA issues Complete Response letter for Avanir’s AVP-825 NDA

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. [More]
Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

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. [More]
PPMD, Santhera Pharmaceuticals collaborate to study Duchenne muscular dystrophy

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

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). [More]
Janssen announces submission of NDA for three-month paliperidone palmitate

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. [More]
Impax announces submission of EMA Marketing Authorization Application for IPX066

Impax announces submission of EMA Marketing Authorization Application for IPX066

Impax Laboratories (Netherlands) B.V., a wholly owned subsidiary of Impax Laboratories, Inc. today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease. [More]
Mylan announces U.S. launch of generic Loestrin 24 Fe

Mylan announces U.S. launch of generic Loestrin 24 Fe

Mylan Inc. today announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe. [More]
Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Glenmark Generics Inc. USA, the subsidiary of Glenmark Generics Limited, has been granted final approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca. [More]
Avanir Pharmaceuticals to publish AVP-825 phase III study results in the journal 'Headache'

Avanir Pharmaceuticals to publish AVP-825 phase III study results in the journal 'Headache'

Avanir Pharmaceuticals, Inc. today announced the publication of results from TARGET, a pivotal phase III study evaluating the efficacy and safety of AVP-825 22mg in the January 2015 issue of Headache (Early access is now available). [More]
FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSA (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). [More]
Neurocrine Biosciences' NBI-98854 drug gets breakthrough designation for tardive dyskinesia

Neurocrine Biosciences' NBI-98854 drug gets breakthrough designation for tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, NBI-98854, in tardive dyskinesia. [More]
Auxilium Pharmaceuticals reports total revenues of $109.6 million for Q3 2014

Auxilium Pharmaceuticals reports total revenues of $109.6 million for Q3 2014

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced financial results for the third quarter ending September 30, 2014. [More]