Somerset Initiates Legal Action Against Fda
TAMPA, Fla., Aug. 6 /PRNewswire/ -- Somerset Pharmaceuticals, Inc.
("Somerset"), which is owned 50% by Watson Pharmaceuticals Inc and 50% by
Mylan Laboratories Inc , today announced that it has filed suit in Delaware
Federal District Court against the Food and Drug Administration (FDA)
seeking an injunction against the FDA.
Somerset Pharmaceuticals, Inc. headquartered in Tampa, FL, is a proprietary
pharmaceutical company which markets Eldepryl(R) (selegiline hydrochloride)
in capsule form for the treatment of patients with late-stage Parkinson's
Disease.
In May, 1996, following FDA approval of its Eldepryl(R) Capsule, Somerset
withdrew its Eldepryl(R) in tablet form from the marketplace out of concern
for patient safety due to the escalating availability of illegally marketed
and counterfeit products. Somerset currently markets Eldepryl(R) only in
capsule form, which is easily identified with several distinguishing and
proprietary markings.
Late yesterday, Somerset verified that the FDA had approved three companies
to market selegiline hydrochloride in tablet form. Somerset believes that
these FDA approvals were improper in that the standards employed were
incapable of determining and confirming bioequivalence, as required by the
FDA's own laws and regulations. Somerset is also challenging the FDA's
position that the documented presence of illegal and counterfeit forms of
selegiline hydrochloride tablets does not warrant the exclusion of the
tablet dosage form from the market place.
Somerset is unable to predict the outcome of this litigation, but intends to
pursue all legal options.
Confusion arose in the marketplace following the announcement of the
availability of these tablet forms.
To minimize any confusion, the following information must be recognized:
-- These tablet forms are not bioequivalent with Eldepryl(R) Capsules
-- These tablet forms are not therapeutically equivalent with Eldepryl(R)
Capsules
-- These tablet forms are not AB rated to Eldepryl(R) Capsules or to the
discontinued Eldepryl(R) Tablets.
-- These tablet forms, under FDA policies, cannot be substituted for
Eldepryl(R) Capsules by pharmacists.
-- These tablet forms, under FDA policies, cannot be interchanged with
Eldepryl(R) Capsules
Somerset cautions that the statements made in this press release and other
forward looking statements made on behalf of the Company, may differ
materially from the Company's actual results, due to such factors including,
but not limited to, changing market conditions, the availability and cost of
raw materials, the impact of competitive products and pricing, the timely
development, FDA approval and market acceptance of the Company's products,
the outcome of litigation described above and other risks detailed
herein and from time to time in the Securities and Exchange Commission
filings of its two parents, Mylan Laboratories, Inc. and Watson
Pharmaceuticals, Inc.
There is no substitute for Eldepryl(R) Capsules. SOURCE Somerset
Pharmaceuticals, Inc.
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