Novartis To File Elidel sNDA For Younger Age Group After Approval
Executive Summary
Novartis plans to file a supplemental NDA for Elidel in patients as young as three months following FDA's Dec. 13 approval of the atopic dermatitis cream in patients older than two years
You may also be interested in...
Quarterly Conference Calls, In Brief
Bristol earnings restatement: Bristol-Myers Squibb expects to "reallocate" approximately $2 bil. in sales recorded during 2000 and 2001 in its upcoming 10-Q filing with the Securities & Exchange Commission. "The expected restatement is based on further review and consideration of the company's accounting for its previously disclosed wholesaler inventory situation and on recent advice from the company's auditors, PricewaterhouseCoopers LLP, based on their ongoing assessment of the company's sales practices in the U.S. pharmaceuticals business and related accounting," Bristol says. The company's accounting for wholesaler inventories is under investigation by the SEC and Department of Justice (1"The Pink Sheet" Oct. 14, In Brief)....One way to boost earnings: Bristol earnings restatement will result in increases in reported revenues and earnings in 2002 (and decreases in 2000 and 2001)...
Quarterly Conference Calls, In Brief
Bristol earnings restatement: Bristol-Myers Squibb expects to "reallocate" approximately $2 bil. in sales recorded during 2000 and 2001 in its upcoming 10-Q filing with the Securities & Exchange Commission. "The expected restatement is based on further review and consideration of the company's accounting for its previously disclosed wholesaler inventory situation and on recent advice from the company's auditors, PricewaterhouseCoopers LLP, based on their ongoing assessment of the company's sales practices in the U.S. pharmaceuticals business and related accounting," Bristol says. The company's accounting for wholesaler inventories is under investigation by the SEC and Department of Justice (1"The Pink Sheet" Oct. 14, In Brief)....One way to boost earnings: Bristol earnings restatement will result in increases in reported revenues and earnings in 2002 (and decreases in 2000 and 2001)...
Elidel launch
Novartis launches eczema treatment Elidel (pimecrolimus 1% cream) in 15, 30, and 100 gm tubes at an AWP of $25.02 , $47.52 and $150, respectively. Elidel is priced between Schering-Plough's Elocon (mometasone furoate) and Fujiwasa's Protopic (tacrolimus). Elidel was approved by FDA Dec. 13 (1"The Pink Sheet" Dec. 17, 2001, p. 5). Novartis has a Phase III trial program in pediatric patients as young as three months, but an sNDA filing hinges on discussions with FDA concerning pediatric data...