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Latest New Drug Application Stories

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...

2014-07-26 00:20:52

REDWOOD CITY, Calif., July 25, 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 announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso(TM) (sufentanil sublingual tablet system). The Company is currently...

2014-07-25 00:21:04

REDWOOD CITY, Calif., July 24, 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 confirmed the PDUFA date for Zalviso remains July 27, 2014. The company recently learned that a rumor circulated online stating the Food and Drug Administration (FDA) had approved Zalviso. As of July 24, 2014 there has been...

2014-07-24 12:28:04

DUBLIN, July 24, 2014 /PRNewswire/ -- Perrigo Company (NYSE: PRGO; TASE) today announced that it has received an AB therapeutic equivalent rating from the U.S. Food and Drug Administration (FDA) for its previously approved New Drug Application (NDA) for testosterone gel 1.0%. FDA concluded that Perrigo's testosterone product is therapeutically equivalent to [AbbVie's] AndroGel 1% and can be substituted with the full expectation that it will produce the same clinical effect and safety...

2014-07-23 08:30:59

MARIETTA, Ga., July 23, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it has filed its initial Investigational New Drug ("IND") application with the Food and Drug Administration ("FDA"). The IND submission, which was filed yesterday, July 22, 2014, is the Company's initial submission for certain indications...

2014-07-21 16:26:17

SAN FRANCISCO and DUBLIN, July 21, 2014 /PRNewswire/ -- Medicines360, a non-profit women's health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's New Drug Application (NDA) for Levosert(TM) (levonorgestrel), a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy. In June 2013, Medicines360 and...

2014-07-17 12:30:54

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant...

2014-07-11 16:23:31

DUBLIN, July 11, 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 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets, 10 mg/10 mg. Actavis' ANDA product is a generic version of Duchesnay Inc.'s Diclegis(®), which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to...

2014-07-08 16:25:34

DUBLIN, July 8, 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 Dalfampridine Extended-release Tablets, 10 mg. Actavis' ANDA product is a generic version of Acorda Therapeutics' Ampyra(®), which is indicated as a treatment to improve walking in patients with multiple sclerosis. Acorda Therapeutics, Inc. filed suit against Actavis on...

2014-07-08 08:31:22

- Toujeo dossier already accepted by EMA - PARIS, July 8, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for...


Word of the Day
toccata
  • In music, a work for a keyboard-instrument, like the pianoforte or organ, originally intended to utilize and display varieties of touch: but the term has been extended so as to include many irregular works, similar to the prelude, the fantasia, and the improvisation.
This word is Italian in origin, coming from the feminine past participle of 'toccare,' to touch.
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