AstraZeneca said on Tuesday that the US Food and Drug Administration (FDA) has approved a new, less stringent pregnancy rating for its nebulized asthma drug Pulmicort Respules (budesonide inhalation suspension).
The product has become only the second inhaled corticosteroid to earn the FDA’s Category B pregnancy rating, the firm said. The other product is the Pulmicort Turbuhaler, a non-nebulized budesonide formulation also marketed by AstraZeneca.
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