NEW YORK — Par Pharmaceutical Cos. and Roxane Laboratories Inc. have resumed shipments of fluticasone propionate nasal spray after a district court in Maryland refused GlaxoSmithKline PLC’s request to block sales of the generic version of its Flonase.
GSK’s lawsuit had postponed shipments of their products, despite the fact that Par markets an authorized generic version of the GSK allergy spray.
Annual sales of Flonase in the United States are estimated at $900 million.
The district court found that the Food and Drug Administration’s approval process for the product was within the law. Because of the court’s decision, the FDA lifted its temporary suspension of sales of the generic versions.
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“Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts,” contends Steven Galson, director of the agency’s center for drug evaluation and research.
The FDA has received several citizen petitions questioning the approval criteria for the drug’s bioequivalence as well as for other aspects of nasal sprays.
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