Latest New Drug Application Stories

FDA Sets 17 July 2013 For MOXDUO® Advisory Committee Meeting

2013-05-17 08:24:10

Committee to Review Respiratory Safety Data Comparing MOXDUO with Components SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO( )New Drug Application (NDA). "The timing is within the expected date range of late June to late July," said Dr. John Holaday,...

Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.

2013-05-17 08:23:15

JERUSALEM, May 17, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule. "We are very pleased to have the FDA clearance to proceed," stated Nadav Kidron, CEO of Oramed. "The upcoming trial is a major milestone...

TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China

2013-05-16 00:20:56

TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs...

Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA

2013-05-13 08:29:34

PARSIPPANY, N.J., May 13, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review. The...

Curemark LLC Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism

2013-04-23 12:32:12

RYE, N.Y., April 23, 2013 /PRNewswire/ -- Curemark LLC announced a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration ("FDA") regarding its CM-AT treatment for Autism. The meeting was held to discuss Curemark's Phase 3 trial results and the pathway for filing an NDA. In view of the positive guidance at this meeting, Curemark will begin filing its NDA. The FDA previously granted Curemark's CM-AT its FAST TRACK designation. "We continue to...

DURECT Announces Submission of New Drug Application for POSIDUR(TM) (SABER®-Bupivacaine)

2013-04-16 08:28:32

CUPERTINO, Calif., April 16, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational product POSIDUR (SABER(®)-Bupivacaine). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. DURECT submitted the NDA as a...

Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind

2013-03-25 08:26:21

WASHINGTON, March 25, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the company held a pre-NDA meeting with the Division of Neurology Products of the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally...

FDA Sets 26 August 2013 As New PDUFA Date For MOXDUO® NDA

2013-03-14 08:29:16

Product Launch Anticipated Before End of Calendar Year Pending Successful NDA Review SYDNEY and BEDMINSTER, N.J., March 14, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee Act (PDUFA) date for action on the Company's resubmitted MOXDUO( )New Drug Application (NDA). "We are pleased that the FDA has formally accepted our resubmitted MOXDUO NDA" said...

Actavis Confirms Generic Exelon® Patch Patent Challenge

2013-03-08 08:23:37

PARSIPPANY, N.J., March 8, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today confirmed that it has filed with the U.S. Food and Drug Administration (FDA) an amendment to its Abbreviated New Drug Application (ANDA) for Rivastigmine Transdermal System to include the 13.3 mg per 24 hours dosage strength. Actavis' ANDA product is a generic version of Novartis' Exelon(®) Patch, which is a prescription medicine used to treat people with mild to moderate dementia associated with...

Depomed Provides Update on SEFELSA(TM) FDA Advisory Committee

2013-03-04 16:25:41

NEWARK, Calif., March 4, 2013 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO), a specialty pharmaceutical company, announced today that the Reproductive Health Drugs Advisory Committee (RHDAC) of the U.S. Food and Drug Administration (FDA) voted 2-12 against approval for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin,( )to treat moderate to severe vasomotor symptoms due to menopause. SEFELSA is the proposed trade name for the medication and was formerly...