Archive for the 'FDA Approval' Category

Medicis warns FDA on Solodyn waiver provisions

SolodynAccording to Medicis Pharmaceutical, the FDA’s waiver provisions for the generic versions of the company’s once-daily oral acne drug, Solodyn (minocycline HCl), will put patients at risk. The company is asking the FDA to approve Solodyn’s generic versions only after in vivo bioequivalence testing for drug strength.

FDA clears Cynosure TriActive LaserDermology System

The FDA has granted clearance to Cynosure’s TriActive LaserDermology System, which is a cellulite treating system based on laser. In addition to the system’s apparent effect on cellulite, it also relives patients of minor pain and muscle spasms. TriActive LaserDermology System improves circulation as well and can be used with various plastic surgery procedures.

FDA approves a drug that reverses effects of local anesthesia

NovalarThe Food and Drug Administration (FDA) has approved a drug that reverses the numbing effects of local anesthesia used by dentists. OraVerse, which was developed by Novalar Pharmaceuticals Inc. is the first dental anesthesia reversal agent on the market for patients of age 6 years or more. According to clinical studies, OraVerse reduces the time it takes for the effect of Novocaine and other numbing agents to wear off to half. Novalar aims to start selling the product in October.

Fraxel gets clearance for fractional ablative resurfacing

Fraxel laser systemReliant Technologies has received FDA approval for its 510(k) submission for its Fraxel repair laser system for Fractional Deep Dermal Ablation (FDDA™) treatment. The system is used for treating wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The Fraxel repair laser system already had clearance for ablation, coagulation and skin resurfacing.