||Approval Dates and Comments|
|TPP Canada authorized the sale of this biologic therapy in October 2004, for the treatment of patients with moderate-to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.|
||Dapsone Gel 5%
|The US FDA accepted an NDA in September 2004, for this gel for|
the treatment of acne vulgaris. It was formerly called Atrisone.
|The US FDA accepted for review in September 2004, an NDA for|
this ointment for the treatment of pain associated with anal fissures.
||Cefdinir Oral Suspension
|The US FDA approved a supplemental NDA in September 2004, for a new|
250mg/5ml dosing option of this antibiotic for use in pediatric patients 6 months to 12 years of age. The more concentrated formulation allows parents to administer fewer teaspoons per dose of the antiobiotic to their children.
||Ultrasonic Skin Permeation
|The US FDA gave marketing clearance in August 2004, to this ultrasonic|
skin permeation device and procedure tray for use with topical lidocaine. This
device applies low frequency ultrasound to a patient’s skin for approximately
15 seconds to create imperceptible, reversible micro-channels through the
stratum corneum making the skin permeable so that the onset of action for
transdermal drugs is accelerated.
|The US FDA issued a nonapprovable letter in September 2004, for this oral|
treatment for the treatment of psoriasis. They listed three nonapprovability
issues: 1) The need for the development of an acceptable risk management
program (which Allergan is in the process of developing); 2) The need for
completion of a noninferiority study in severe psoriasis; 3) Satisfaction of a
US FDA deficiency letter regarding the manufacture of the oral tazarotene
capsules. Allergan is working with the US FDA to resolve these issues.
||The US FDA and Abbott Pharmaceuticals notified healthcare professionals in November 2004, of revisions to the WARNINGS section of the prescribing information, indicated for HUMIRA® (adalimumab) which is indicated for the treatment of rheumatoid arthritis. Serious infections have been reported with the combined use of HUMIRA® and anakinra (Kineret®, Amgen), including hypersensitivity reactions, such as anaphalaxis, and hematologic events such as pancytopenia and aplastic anemia.|
|The US FDA announced in November 2004, that the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 made significant changes to the generic drugs approval process designed to provide more certainty to the generic drug approval process and help get generic drugs to the market more quickly. A guidance of industry entitled “Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers”|