FDA approves Trimel Pharmaceuticals’ Natesto testosterone nasal gel
TORONTO — Trimel Pharmaceuticals on Wednesday announced that the Food and Drug Administration has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.
"In my practice, I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida. "For these patients seeking to restore their testosterone levels, Natesto will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market."
According to Trimel, it conservatively is estimated that nearly 13 million American men may have low testosterone levels. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections and oral tablets, as well as a buccal patch.
"The FDA approval for Natesto is a major achievement for our company, as it validates our clinical research and development efforts, as well as reinforces our commitment to provide innovative treatment options for patients," said Tom Rossi, Trimel Pharmaceuticals president and CEO. "Men suffering from ‘Low T’ will now have a different option to raise their testosterone levels. This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children. We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it."
Banana Boat, actress Busy Philipps launch summer sweepstakes
SHELTON, Conn. — Energizer Personal Care, the makers of Banana Boat sunscreen, along with actress Busy Philipps, announced on Thursday the launch of the Best Summer Ever Sweepstakes.
The Banana Boat Best Summer Ever Sweepstakes gives families the chance to spin the Wheel of Fun, hosted on the Banana Boat Facebook fan page, for a chance to win daily prizes, including gift cards, Banana Boat brand gift baskets, movie passes for four and a family fun prize pack. Each spin also automatically enters participants into a sweepstakes for a chance to win the grand prize family trip to a Treesort — a tree house resort adventure.
Banana Boat also is equipping families to have the Best Summer Ever through its offering of four new sunscreens:
- Banana Boat Triple Defense Sunscreen for Men Lotion and Clear UltraMist: A full line of sunscreens designed specifically for men that contains ActiveProtect Technology, provides heavy-duty sun protection, hydrates skin and combats odor;
- Banana Boat Kids Free Clear UltraMist Sunscreen: An alcohol-free, tear-free, sting-free kids clear spray;
- Banana Boat Sport Performance Clear UltraMist Sunscreen with Powerstay Technology: Specifically designed for the sport enthusiast and active individual who doesn’t want to be slowed down while out in the sun; and
- Banana Boat Protect & HydrateTM Sunscreen Clear UltraMist: A 2-in-1 combination of sunscreen and all-day moisturizer.
Mylan launches generic version of GlaxoSmithKline’s Malarone tablets
PITTSBURGH — Mylan on Thursday announced that it has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline’s Malarone tablets.
Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application for this product, which is indicated to prevent Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria.
Atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, had U.S. sales of approximately $89.4 million for the 12 months ended March 31, 2014, Mylan reported, citing IMS Health.