E-DRUG: Sumamed registered in USA? (3)
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[nice to see that E-drug can solve queries in 10 mins! Discussion closed!
WB]
Dear E-druggers
Rakesh Chaurasia asked whether Azithromycin Tablets 500mg (sold under
the brand name 'Sumamed' by Pliva dd) was approved by the CDER as a
generic substitute of Pfizer's 'Zithrox'.
Wilbert then asked how to check at FDA/CDER whether a particular drug
is registered.
The FDA's Orange Book is searchable at
http://www.fda.gov/cder/ob/docs/queryai.htm
Searching for 'azithromycin' yields only Pfizer's "Zithromax' range -
the oral tablets, suspensions and the injectable form are all listed as
the "Reference Listed Drug" (this is "the standard to which all generic
versions must be shown to be bioequivalent" - see
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm#Reference%20Listed%20D
rug
for the explanation). There are no generics listed. If there had been,
the Therapeutic Equivalence Code would have indicated the status (see
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm#Therapeutic%20Equivale
nce-Related%20Terms
for explanations of the various codes used.
The FDA's Orange Book (or Approved Drug Products with Therapeutic
Equivalence Evaluations) satisfies the requirement of the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments) that the
Agency make publicly available a list of approved drug products that is
updated monthly. In gneral, anything with an "A" code is considered
theraputically equivalent, and anything with a "B" code is not
considered theraputically equivalent. AS explained on the site: "If a
prescription drug product is available from more than one source
(multisource), a therapeutic equivalence code will be displayed. If a
product is therapeutically equivalent to one or more products or to an
appropriate reference, it will be designated with a code beginning with
"A"."
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Experimental and Clinical Pharmacology
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
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