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Latest New Drug Application Stories

2014-10-16 08:31:22

DUBLIN, Oct. 16, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) 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 Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR(®), which is a central nervous system stimulant indicated for the treatment of Attention Deficit...

2014-10-10 08:24:17

CUPERTINO, Calif., Oct. 10, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that data for POSIDUR((TM)) (SABER(®)-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia, is being presented at ANESTHESIOLOGY((TM)) 2014, the annual meeting of the American Society of Anesthesiologists (ASA). The meeting will be held October 11-15, 2014 at the Ernest N. Morial Convention Center in New Orleans....

2014-09-29 12:30:04

PRINCETON N.J., Sept. 29, 2014 /PRNewswire/ -- Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage. Guerbet is being recognized for its efforts related to the shortage of Ethiodol (ethiodized oil) injection, including acquiring the new drug application, submitting several post-approval supplements to restart...

2014-09-26 08:25:17

REDWOOD CITY, Calif., Sept. 26, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided an update on the plans for the resubmission of the Company's New Drug Application (NDA) for Zalviso(TM) (sufentanil sublingual tablet system). The Company recently held a teleconference with representatives from the...

2014-09-25 16:26:46

DUBLIN, Sept. 25, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) 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 Buprenorphine Transdermal System, 5 mcg/hr, 10 mcg/hr and 20 mcg/hr. Actavis' ANDA product is a generic version of Purdue Pharma's Butrans(®), which is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for...

2014-09-25 08:27:49

BUENA, N.J., Sept. 25, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed. The acquisition includes the regulatory rights and documents for 17 injectable products and 1 suppository product. All of these products had been previously approved by the US FDA as...

2014-09-25 08:27:36

BRIDGEWATER, N.J., Sept. 25, 2014 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, is pleased to announce that an Investigational New Drug application (IND) for Neutrolin(®) was submitted to the United States Food and Drug Administration (FDA) on Wednesday, September 24, 2014. The IND includes a pivotal Phase 3 protocol...

2014-09-17 08:31:00

HAYWARD, Calif., Sept. 17, 2014 /PRNewswire/ -- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY(TM) (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to...

2014-09-15 08:28:36

MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under...

2014-08-28 12:29:56

PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). This product is the generic version of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS)....


Word of the Day
negawatt
  • A unit of saved energy.
Coined by Amory Lovins, chairman of the Rocky Mountain Institute as a contraction of negative watt on the model of similar compounds like megawatt.