AstraZeneca is seeking to fend off generic competition for the cholesterol drug Crestor following its FDA approval for the treatment of the rare disease homozygous familial hypercholesterolaemia (HoFH), The New York Times reported Monday.
Following approval of Crestor for HoFH, an indication for which the therapy has received orphan drug designation, AstraZeneca immediately asked the agency to block generic competition for the drug because detailed prescribing information about using the drug for the rare disease cannot be included on the label for seven years.
The drugmaker argued that because of this, it would be illegal and dangerous for generic versions to be available.
The agency could approve generic versions of Crestor as soon as July 8.
Previously, Spectrum Pharmaceuticals failed in a similar attempt to block generic competition fo the cancer therapy Fusilev, while a US court previously upheld the FDA's decision to permit generic competition for Otsuka Pharmaceutical's antipsychotic Abilify after the therapy was approved for treating a rare disease.
Previously, Congress amended legislation in 2002 after Bristol-Myers Squibb attempting to delay generic competition for the adult-onset diabetes drug Glucophage after the company won approval for the therapy for use in children.
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