Generic cromolyn sodium
This article was originally published in The Tan Sheet
Executive Summary
Bausch & Lomb receives FDA clearance for private label OTC nasal solution July 3. B&L's application (ANDA 75-702) appears to be first approved by agency for generic equivalent to Pharmacia's NasalCrom, which lost marketing protection July 3, 2000 after receiving six months of pediatric exclusivity. Perrigo said it will introduce a cromolyn sodium product this year. In late March, Pharmacia received approval of a new age indication for NasalCrom, allowing for use in children ages two to five (1"The Tan Sheet" April 9, p. 11)
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Generic cromolyn sodium
Perrigo ANDA 75-427 for equivalent to Pharmacia's NasalCrom approved Dec. 12. Private labeler becomes second ANDA holder to receive FDA clearance to market cromolyn sodium nasal spray; Bausch & Lomb's application was approved in July (1"The Tan Sheet" July 9, In Brief)...
Generic cromolyn sodium
Perrigo ANDA 75-427 for equivalent to Pharmacia's NasalCrom approved Dec. 12. Private labeler becomes second ANDA holder to receive FDA clearance to market cromolyn sodium nasal spray; Bausch & Lomb's application was approved in July (1"The Tan Sheet" July 9, In Brief)...
Generic cromolyn sodium
Perrigo ANDA 75-427 for equivalent to Pharmacia's NasalCrom approved Dec. 12. Private labeler becomes second ANDA holder to receive FDA clearance to market cromolyn sodium nasal spray; Bausch & Lomb's application was approved in July (1"The Tan Sheet" July 9, In Brief)...