Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room: 1061
Rockville, Maryland 20852
Groron / New London Labomories
Pfizer Inc
Eastern Point Road’
Woton, CT 06340
Re:
Amorphous Atorvastatin
Dear Sir or Madam:
CJTIZEN PETITION
On July 28,2005,, we wrote to Gary Buehler to provide ba
und information on
amorphous versions of atorvastin that we believe may be relevant to FDA’s Fonsideration of
generic drugs that contain. such polymorphs. That letter is aached as Exhibit A. In a letter dated
August 30,2005, attached as Exhibit B, M?. Buehler requested that we file apetition containing
the same information. He noted that the citizen petition process wouid.permit others an
opportunity to comment on the points we raise and also permit Pfizer the ap~o~~~~ to comment
on the views and opinions of others that may be submitted in the citizen petition file. We submit
this petition in response to Mr. Buehler’s request.
A.
Action Reauested
Pfizer asks that FDA consider the, information provided in the July 28 letter, together
with any additional in,formation that may be submitted to the petition f&by Sfizer or others, in
FDA’s decisions concernn-rg approvals of generic versions of atorvaStat&’
B.
Statement of Grounds
We incorporate the July 28 letter (Exhibit A) as our st~~me~t of grounds for this petition.
In addition, we add. further scientific evidence which supports the contention that multiple
“amorphous” forms of atorvastatin, calcium exist (Exhibit I)). These data consist of small angle
x-ray scattering (SAXS) profiles obtained using syn~hrotroti
radiation, and demonstrate that
“amorphous” Forms 23 and 27 are structurally different, with Form 23 being more ordered than
Form 27, as also demonstrated by powder x-ray diffraction in A~~~~t
1 of Exhibit A.
* Mr. Buehler’s letter notes that the issues raised in the July 28 letter may be of s&nificant
interest to others. We respectfully suggest that FDA consider scheduhng a public meeting on
these issues. At th