Jonexa (hylastan) is a bacterially fermented product derived from hyaluronan that is indicated for the treatment of pain associated with OA of the knee and administered in one or two injections. Genzyme expects to launch Jonexa in select European Union markets and Hong Kong in 2010 because they believe opportunity exists in those markets for […]
Continue ReadingFDA Approval: Viibryd
January 24, 2011
Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A […]
Continue ReadingFDA Approval: Brilique
December 06, 2010
LONDON, Dec 6 (Reuters) – AstraZeneca’s new heart medicine Brilique — or Brilinta — won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world’s second biggest-selling drug, next year. AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling […]
Continue ReadingFDA Approval: Halaven
November 16, 2010
FDA Approves Eisai Inc. (ESALF.PK)’s Halaven For Late-Stage Breast Cancer 11/15/2010 SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. Breast cancer is the second leading […]
Continue ReadingFDA Approval: Ofirmev
November 10, 2010
PRNewswire via COMTEX News Network/ — Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced last week that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV(TM) (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to […]
Continue ReadingFDA Pharmaceutical Approval: Suboxone
August 31, 2010
According to ClinicaSpace, MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone […]
Continue ReadingFDA Pharmaceutical Approval: Glassia
August 12, 2010
Kamada Ltd. (KMDA.TA) received FDA Approval for AATD Drug Glassia. According to the Alpha-1 Association, Alpha-1 Antitrypsin Deficiency (Alpha-1) is a condition that is passed on from parents to their children through genes. This condition may result in serious lung and/or liver disease at various ages in life. Alpha-1 antitrypsin is a protein that is […]
Continue ReadingFDA Pharmaceutical Approval: Zuplenz
August 10, 2010
FDA Approves Strativa Pharmaceuticals’ Zuplenz (ondansetron) Oral Soluble Film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. “The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients,” said John A. […]
Continue ReadingHappy 50th Anniversary!!
May 17, 2010
The pill. No, not a pill, but THE pill. The pill that sexually revolutionized women and the control over their bodies. The pill that wrapped itself in religious dilemma and political controversy. The pill that to this day still raises concerns over morality and safety. This year marks the 50th anniversary of this medicinal wonder. […]
Continue ReadingHappy Birthday BOTOX!
March 31, 2010
While the results are temporary, I have a feeling BOTOX® is here to stay. Did you know BOTOX is the most popular non-surgical beauty treatment in the world? It is also one of the world’s most versatile and most widely researched medicines in the world. Botulinum toxin, a purified protein derived from the bacterium […]
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