Articles By Cyndi Root

81. FDA Approves Generic Drug Combination For HIV-1 2/13/2014

    The Food and Drug Administration (FDA) published consumer guidance, notifying the public that the agency has approved a generic drug combination for HIV-1 infection.

82. FDA Rejects Migraine Drug From RedHill Biopharma And IntelGenx 2/11/2014

    RedHill Biopharma and IntelGenx issued a press release detailing the Food and Drug Administration’s (FDA) complete response letter to RHB-103, a drug for acute migraines. The federal agency required no further clinical studies as the drug’s efficacy and safety was accepted.

83. FDA Grants Orphan Drug Status To Edison Pharmaceutical's EPI-743 2/11/2014

    Friedreich's Ataxia Research Alliance (FARA) has announced in a press release that the FDA has granted orphan drug status to Edison Pharmaceutical’s EPI-743 (vatiquinone). The drug treats Friedreich’s ataxia, a rare nervous system disorder.

84. The Drug Channels Institute's Economic Report On Pharmacies 2/11/2014

    The Drug Channels Institute has released a report, “The 2013–14 Economic Report on Retail, Mail, and Specialty Pharmacies.” The report, written by Adam J. Fein, Ph.D., includes data, information, and analysis on the U.S. pharmacy industry

85. Weekly FDA Enforcement Report for Drugs And Biologics 2/7/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 5, 2014.

86. Weekly FDA Enforcement Report for Drugs And Biologics 1/31/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for January 29, 2014.

87. Janssen Pharmaceuticals On Trial For Topamax 1/29/2014

    Janssen Pharmaceuticals faces trials on its epilepsy and migraine drug Topamax early this year. The trials come on the heels of two judgments for plaintiffs that asserted Topamax caused birth defects and the company failed to warn them of the risk. The company intends to appeal both verdicts.

88. Weekly FDA Biologics Enforcement Report 1/27/2014

    The Food and Drug Administration (FDA) has released its Biological product Enforcement Report for January 22, 2014.

89. Weekly FDA Drugs Enforcement Report 1/27/2014

    The Food and Drug Administration (FDA) has released its Enforcement Report for January 22, 2014.

90. FDA Gives QIDP Status To The Medicines Company's Antibiotic Carbavance 1/22/2014

    The Food and Drug Administration (FDA) has moved The Medicines Company’s new drug Carbavance forward, according to a press release issued by the company. The FDA designated Carbavance as a Qualified Infectious Disease Product (QIDP), which gives it FDA priority review and “fast track” status. Additionally, QIDP status allows the company five years of exclusivity when approved. The designation allows six indications that include febrile neutropenia, complicated urinary tract infections, intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.