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)...
Alpharma
Company will ship generic Cromolyn Sodium Nasal Solution USP to several major drugstores in the first half of August, firm says. Alpharma received final approval of ANDA 74-800 for its Nasalcrom equivalent July 26 and is second private labeler to receive FDA clearance; Bausch & Lomb's generic cromolyn sodium was approved in early July (1"The Tan Sheet" July 9, p. 28). Pharmacia's Nasalcrom lost marketing exclusivity July 3, 2000 after receiving six months of pediatric exclusivity
Pharmacia NasalCrom Expanded Use In Young Children Approved By FDA
Pharmacia will use a professional detailing force to notify allergists about NasalCrom nasal spray's newly approved indication for use in children ages two to five.