Home » APP Pharmaceuticals receives FDA approval to advertise Aztreonam for Injection.

APP Pharmaceuticals receives FDA approval to advertise Aztreonam for Injection.

Food and Medication Administration to advertise Aztreonam for Injection, USP in two dosage strengths. APP’s Aztreonam is usually AP-rated, bar-coded and latex-free. According to IMS data, 2009 product sales of the branded product in the United States were around $86 million. The acceptance of Aztreonam further expands APP’s leading anti-infective product line. ‘The authorization of APP’s Aztreonam marks the first generic entrant into the market and provides clinicians with an alternative to the branded drug,’ said John Ducker, president and chief executive officer of APP Pharmaceuticals.

Following the week 48 visit, participants continued to receive blinded treatment until week 96, with visits scheduled 12 weeks every. On completion of the entire week 96 visit, all the individuals were offered the opportunity to keep the treatment until week 144 within an open-label fashion. The Abbott RealTime HIV-1 assay was used to identify the plasma degree of HIV-1 RNA . CD4+ T-cell counts were assessed through movement cytometry in a central laboratory. Adverse events, significant adverse events, and laboratory measurements had been assessed at each visit and graded according to the criteria of the Division of the Obtained Immunodeficiency Syndrome at the National Institute of Allergy and Infectious Diseases of the National Institutes of Wellness.16 Viral genotype was analyzed at the screening visit.Following the week 48 visit, participants continued to receive blinded treatment until week 96, with visits scheduled 12 weeks every. On completion of the entire week 96 visit, all the individuals were offered the opportunity to keep the treatment until week 144 within an open-label fashion. The Abbott RealTime HIV-1 assay was used to identify the plasma degree of HIV-1 RNA . CD4+ T-cell counts were assessed through movement cytometry in a central laboratory. Adverse events, significant adverse events, and laboratory measurements had been assessed at each visit and graded according to the criteria of the Division of the Obtained Immunodeficiency Syndrome at the National Institute of Allergy and Infectious Diseases of the National Institutes of Wellness.16 Viral genotype was analyzed at the screening visit.