New Drug Application News and Research

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BioDelivery Sciences International submits BUNAVAIL NDA to FDA

BioDelivery Sciences International, Inc. announced today that it engaged in a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding BUNAVAIL for the maintenance treatment of opioid dependence.

10 Jun 2013

AVEO Oncology receives Complete Response letter from FDA for tivozanib NDA

AVEO Oncology today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration informing the company that the FDA will not approve in its present form the New Drug Application for AVEO's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma.

10 Jun 2013

Actavis files ANDA to market Propofol Injection

Actavis, Inc. today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Propofol Injection 10mg/mL.

7 Jun 2013

Soligenix receives FDA Fast Track designation for SGX942 to treat patients with oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company, announced today that its SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients has received "Fast Track" designation from the US Food and Drug Administration.

3 Jun 2013

Shire resolves patent infringement lawsuit against Teva relating to INTUNIV tablet

Shire LLC has settled its litigation against Teva Pharmaceuticals USA Inc. ("Teva") in connection with Teva's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV (guanfacince) Extended Release Tablets for the treatment of Attention Deficit Hyperactivity Disorder.

3 Jun 2013

Depomed receives complete response letter for SEFELSA NDA

Depomed, Inc., a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration issued a complete response letter to the New Drug Application for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.

1 Jun 2013

Vanda Pharmaceuticals announces submission of tasimelteon NDA to FDA

Vanda Pharmaceuticals Inc. today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for tasimelteon, a circadian regulator.

31 May 2013

FDA issues complete response letter to Endo's NDA for AVEED injection

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. announced today that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism.

31 May 2013

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has accepted for review the company's supplemental new drug application for COPAXONE (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis.

31 May 2013

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder.

29 May 2013

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Pacira Pharmaceuticals, Inc. today announced findings from the completed first part of its Phase 2/3 clinical trial assessing the use and administration of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose injection femoral nerve block for total knee arthroplasty surgery.

29 May 2013

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

Valeant Pharmaceuticals International, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for efinaconazole for the treatment of onychomycosis.

28 May 2013

Omthera to be acquired by AstraZeneca

AstraZeneca today announced that it has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey, focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.

28 May 2013

FDA clears Omeros' OMS824 IND for treatment of Huntington's disease

Omeros Corporation today announced that its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration.

23 May 2013

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

Merck releases statement on FDA's Advisory Committee meeting about suvorexant

Merck, known as MSD outside the United States and Canada, today provided the following statement after the conclusion of the Peripheral and Central Nervous System Drugs Advisory Committee meeting of the U.S. Food and Drug Administration about suvorexant, Merck's investigational medicine to treat insomnia.

23 May 2013

$Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS$

Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

Upsher-Smith Laboratories, Inc. today announced the successful completion of its global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology.

23 May 2013

Takeda, Lundbeck announce presentation of data from four studies that evaluate vortioxetine for MDD

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration for the treatment of major depressive disorder.

20 May 2013

Alnylam reports pre-clinical data from ALN-AS1 program for treatment of AIP

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented key pre-clinical proof-of-concept data from its RNAi therapeutic program targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of porphyria including acute intermittent porphyria.

18 May 2013

FDA to review QRxPharma's resubmitted MOXDUO NDA in July 2013

QRxPharma Limited announced today the US Food and Drug Administration has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO New Drug Application.

18 May 2013

New Drug Application News and Research

BioDelivery Sciences International submits BUNAVAIL NDA to FDA

AVEO Oncology receives Complete Response letter from FDA for tivozanib NDA

Actavis files ANDA to market Propofol Injection

Soligenix receives FDA Fast Track designation for SGX942 to treat patients with oral mucositis

Shire resolves patent infringement lawsuit against Teva relating to INTUNIV tablet

Depomed receives complete response letter for SEFELSA NDA

Vanda Pharmaceuticals announces submission of tasimelteon NDA to FDA

FDA issues complete response letter to Endo's NDA for AVEED injection

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

Omthera to be acquired by AstraZeneca

FDA clears Omeros' OMS824 IND for treatment of Huntington's disease

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Merck releases statement on FDA's Advisory Committee meeting about suvorexant

Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

Takeda, Lundbeck announce presentation of data from four studies that evaluate vortioxetine for MDD

Alnylam reports pre-clinical data from ALN-AS1 program for treatment of AIP

FDA to review QRxPharma's resubmitted MOXDUO NDA in July 2013

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