Abbott announced that the FDA has approved its RealTime HBV assay for measuring the amount of hepatitis B virus (HBV) in human plasma or serum from individuals chronically infected with HBV.

Reckitt Benckiser announced that the FDA has approved Suboxone (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence in conjunction with counseling and psychosocial support.

The FDA has approved Tekamlo (aliskiren and amlodipine tablets, from Novartis), a single, combination therapy tablet for the treatment of hypertension, alone or with other antihypertensive agents.

Strativa has made available Oravig (miconazole buccal tablets) for the treatment of oropharyngeal candidiasis (OPC) in patients ≥16 years of age.

Actelion Pharmaceuticals announced that the FDA has approved the brand name Veletri for its epoprostenol for injection.

The FDA has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra (immune globulin subcutaneous [Human] 20% Liquid, from CSL Behring) from 18 to 24 months.

Watson announced that ella (ulipristal acetate tablet), an oral emergency contraceptive, will be available in the fourth quarter of 2010 by prescription only.

The FDA has approved NovoSeven RT (coagulation Factor VIIa [recombinant] room temperature stable, from Novo Nordisk) in an 8mg vial size.

The FDA has approved a longer duration of therapy with Valcyte (valganciclovir, from Genentech) in adult renal transplant patients at high risk for cytomegalovirus (CMV) disease.

Mission Pharmacal announced that Uribel (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate capsules) is available for the treatment of irritative voiding; for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections; and for the relief of urinary tract symptoms caused by diagnostic procedures.