Proton Pump Inhibitors - CME Conferences

6 th Annual Primary Care Spring Conference Thursday, April 12, 2012
FDA Requirements for Generic
Ophthalmics
• The following companies that offer generic latanoprost in
the same formula as Xalatan include:
– Brand Xalatan by Pfizer - $81.85 AWC/2.5ml 0.005% soln
– Bausch + Lomb - $13.43 AWC/2.5ml 0.005% soln
– Falcon Pharmaceuticals Ltd., an affiliate of Alcon Laboratories,
Inc. (owned by Novartis) - $10.00 AWC/2.5ml 0.005% soln
– Apotex Corp. - $53.12 AWC/2.5ml 0.005% soln
– Greenstone LLC (owned by Pfizer) - $13.38 AWC/2.5ml 0.005%
soln
– Mylan – $6.90 AWC/2.5ml 0.005% soln
– Note that all of the above have FDA Therapeutic Equivalent
Codes of AT and are considered by the FDA therapeutically
equivalent
FDA Orange Book for Solutions
• All solutions and DESI drug products containing the
same active ingredient in the same topical dosage
form for which a waiver of in vivo bioequivalence has
been granted and for which chemistry and
manufacturing processes are adequate to
demonstrate bioequivalence, are considered
therapeutically equivalent and coded AT.
Pharmaceutically equivalent topical products that
raise questions of bioequivalence, including all post-
1962 non-solution topical drug products, are coded
AB when supported by adequate bioequivalence
data, and BT in the absence of such data.
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Wayne Weart, Pharm D
Cost Effective Rx