Aesthetics Product Guide

Medicis warns FDA on Solodyn waiver provisions

Jim Marino — Thu, 14 Aug 2008 15:05:57 +0000

According 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.

Mentor site on breast enhancement, cosmetic procedures

Jim Marino — Thu, 07 Aug 2008 17:59:49 +0000

Mentor Corporation has launched an online educational resource for women considering breast augmentation and other cosmetic procedures. The site, www.LoveYourLook.com, is aimed at providing the most comprehensive information for women researching cosmetic surgery. This would help women make informed decisions and contact qualified physicians in their area. The site includes information on Mentor’s MemoryGel™ silicone implants.

Carbamazepine may cause serious skin complications

Jim Marino — Wed, 09 Jul 2008 20:03:23 +0000

According to an advisory issued by Health Canada, patients taking epilepsy drug carbamazepine may face serious skin complications, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. The advisory further states that while all patients taking the drug are at risk, the risk increases ten-fold in patients of Asian origin.

FDA clears Cynosure TriActive LaserDermology System

Jim Marino — Thu, 26 Jun 2008 20:10:47 +0000

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.

DUSA enrollment for Phase IIb trial of acne product

Jim Marino — Tue, 24 Jun 2008 16:53:03 +0000

DUSA Pharmaceuticals Inc. has announced the completion for the enrollment of acne Phase IIb trial. The company plans to study the effects of multiple broad area photodynamic therapy (PDT) treatments, Levulan®, Kerastick® and BLU-U® brands as compared to the use of BLU-U® alone. Thus, the company will be able to evaluate the incremental advantage of Levulan® along with BLU-U® blue light therapy in acne treatment.

FDA approves a drug that reverses effects of local anesthesia

Jim Marino — Wed, 04 Jun 2008 04:42:41 +0000

The 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.

Revolutionary plastic surgery videos helping patients

Jim Marino — Thu, 15 May 2008 15:58:11 +0000

Manhattan-based facial plastic surgeon, Oleh Slupchynskyj, has developed breakthrough educational videos for YouTube, which are paving the way for how the medical community can inform consumers about plastic surgery do’s and don’ts, risks and benefits. Created initially for patients who wanted to learn all aspects of and watch firsthand the most popular plastic surgery procedures before choosing to undergo treatment themselves, each video has received the highest of ratings since just being posted on YouTube. The videos include live surgery footage, patient testimonials plus before-and-after photos for facelift surgery, rhinoplasty or nose surgery, and lip augmentation.

XenaCare Holdings launches UV sun defense pill

Jim Marino — Tue, 13 May 2008 16:24:58 +0000

XenaCare Holdings Inc. has officially launched its new product called the SunPill® after an 8-month development program. The SunPill® is a dietary supplement that helps the skin protects itself from the harmful rays of the sun. The proprietary combination of ingredients with powerful antioxidant properties in the product helps the body’s own natural defense when it comes to exposure to the sun.

Take cosmetic injectables only when prescribed

Jim Marino — Tue, 06 May 2008 15:06:24 +0000

The Physicians Coalition for Injectable Safety has issued a warning against the growing popularity of cosmetic injectables being offered as prizes or gifts. The Coalition leader, Renato Saltz, MD, of Salt Lake City, Utah, says that these injectables are medical treatments and should be taken only if prescribed by a physician.

ZymoGenetics presents positive results on RECOTHROM Thrombin

Jim Marino — Mon, 05 May 2008 16:55:38 +0000

ZymoGenetics Inc. has presented results at the American Burn Association annual meeting from a clinical trial with RECOTHROM™ Thrombin, a topical (Recombinant) administered by spray device to burn wound excision sites. The study revealed that the topical application of RECOTHROM using a pump spray device was well tolerated and it demonstrated a similar safety profile and rate of antibody formation to that observed in the rThrombin Phase 3 clinical trial.