Loratadine approvals
This article was originally published in The Tan Sheet
Executive Summary
Wyeth Consumer Care's ANDA 75-822 for orally disintegrating 10 mg loratadine tablets (equivalent to Schering-Plough's Claritin RediTabs) approved by FDA Feb. 10 with180 days of marketing exclusivity. Wyeth already markets the same product under the brand name Alavert, which was approved under a 505(b)(2) application in December (1"The Tan Sheet" Dec. 23, 2002, p. 5). Separately, Andrx's ANDA 75-706 for loratadine 10 mg/pseudoephedrine 240 mg combination, approved Feb. 21, also receives 180-day exclusivity. Andrx will supply Perrigo with the product, which plans to ship the Claritin-D 24-Hour equivalent in mid-June (2"The Tan Sheet" Feb. 3, 2003, p. 13)...
You may also be interested in...
Perrigo Loses Acetaminophen Supplier, Gains Loratadine Deal
The loss of a supplier could cost Perrigo up to $18 mil. in acetaminophen product sales in fiscal year 2004, the private labeler said
Wyeth Alavert Approval Sparks Loratadine Price Wars, Fight For OTC Share
Wyeth Consumer Healthcare is staking a claim to the OTC loratadine market with Alavert pricing of 56¢ to $1 per orally disintegrating tablet and high-value coupons
EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: