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That the U.S. Food and Drug Administration had previously approved a different drug product with higher levels of SLS did not render the decision unreasonable.
On February 1, 2017, the Federal Court dismissed Apotex's
application for judicial review of the Minister of Health's
refusal to approve its Abbreviated New Drug Submission (ANDS) for
Apo-Progesterone: Apotex Inc v Canada (Health), 2017 FC 127. The Court found no breach of
procedural fairness, and concluded that the Minister's decision
to refuse to approve the ANDS on the basis that the drug product
contained unusually high levels of sodium lauryl sulfate
(SLS) was reasonable. That the U.S. Food and Drug
Administration had previously approved a different drug product
with higher levels of SLS did not render the decision
unreasonable.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.
