Latebreakers: FDA OK's OTC Zyrtec
FDA approves allergy treatment Zyrtec (cetirizine HCl) for over-the-counter use
McNeil Consumer Healthcare, a division of McNeil-PPC, has received approval for the allergy treatment Zyrtec (cetirizine HCl) to be used without a prescription for adults and children. Zyrtec relieves symptoms caused by perennial and seasonal allergic rhinitis, commonly referred to as indoor and outdoor upper respiratory allergies. Zyrtec also relieves itching due to hives. The approval comes one week after the FDA granted the company approval to market Zyrtec-D 12 Hour (cetirizine HCl 5 mg/pseudo ephedrine HCl 120 mg), which combines Zyrtec with a decongestant. Zyrtec-D and Zyrtec will be available OTC in late January 2008 in their original prescription strength. With Zyrtec's patent expiring this month, generic Rx versions are also expected to make their debut.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
