Watson aims for August launch of EC
This article was originally published in The Tan Sheet
Executive Summary
The maker of the just-approved Next Choice emergency contraceptive, a generic of Teva's Plan B (levonorgestrel), applies to make the drug available for nonprescription sale upon the expiration of Teva's market exclusivity Aug. 24. A spokeswoman said June 29 that Watson Pharmaceuticals is confident FDA will approve the Next Choice nonprescription application, but does not know whether the decision will come before Plan B loses exclusivity. FDA likely will apply to non-Rx levonorgestrel generics the same age restriction on pharmacy-only sales it imposed on Plan B (1"The Tan Sheet" June 29, 2009). Watson reserves the right to later seek universal OTC sales status, the spokeswoman said
You may also be interested in...
Generic Rx Plan B Approval Points To Possible OTC Equivalents In Near Future
FDA's approval of a generic prescription-only Plan B makes a nonprescription generic of the emergency contraceptive likely, potentially as early as August
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.