Quantcast

Latest New Drug Application Stories

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...

2014-07-02 08:27:01

Jazz Pharmaceuticals to own worldwide rights to defibrotide at closing DUBLIN, July 2, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) under which a subsidiary of Jazz Pharmaceuticals plc (Jazz) will acquire from Sigma-Tau rights to defibrotide in the United States (U.S.) and all other countries in the Americas. Sigma-Tau holds rights to market...

2014-06-30 08:29:59

DUBLIN, June 30, 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 Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv(®), which is a partial opioid agonist indicated for the maintenance treatment of...

2014-06-20 08:23:55

BUENA, N.J., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted two additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to six, with seventeen submissions now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner,...


Word of the Day
bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
Related