Loratadine to Be Sold Without Prescription
According to Schering-Plough, FDA's decision covers all five formulations of loratadine at their original prescription strengths. The company estimated that the product will be available in consumer-oriented packaging by mid-December.
Loratadine was first approved for marketing in 1993 as a prescription product for use in the treatment of nasal and nonnasal symptoms of seasonal allergic rhinitis. The product is also indicated for the treatment of chronic idiopathic urticaria.
The switch to nonprescription status means that Schering-Plough will no longer supply loratadine prescription-only packaging. Pharmacies may, however, use their remaining stocks of loratadine to fill unexpired prescriptions for the product, according to Schering-Plough.
The company's patent for loratadine expires Dec. 19, after which time generic products may enter the market.