Coola Suncare inks retail partnership with Ulta Beauty
SAN DIEGO — Coola Suncare, a maker of organic sun care products, has announced a new retail partnership with Ulta Beauty.
Through the partnership, Ulta will introduce Coola’s collection of products to more than 700 of its beauty doors across the United States and on Ulta.com in March.
The products that will be available include —
- Liplux SPF30 original and vanilla/peppermint
- Classic Face SPF 30 cucumber and unscented
- Classic Body SPF 30 plumeria
- Mineral Face SPF 30 Matte cucumber and unscented Matte tint
- Mineral Face SPF 20 rose essence
- Mineral Sport SPF 35 citrus mimosa
- Sport Sprays in SPF 30 unscented, pina colada and citrus mimosa
- Environmental Repair Plus Radical Recovery After Sun Lotion
"Consciously choosing to develop a line of products using ingredients that are organic, sustainable and locally sourced, much like the foods we prefer to eat, Coola offers sun protection for a range of skin types and lifestyles. The products are uniquely formulated for different parts of the body, from the sensitive nature of the face, to the versatile body and the demands of sport. We are confident that Coola will be the ideal solution for Ulta consumers across the country," stated Chris Birchby, founder and CEO of Coola Suncare.
FDA gives approval to Impavido
SILVER SPRING, Md. — The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. It’s the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
Impavido is an oral medication approved to treat the three main types of leishmaniasis: visceral leishmaniasis, which affects internal organs; cutaneous leishmaniasis, which affects the skin; and mucosal leishmaniasis, which affects the nose and throat. It’s intended for patients ages 12 years or older.
The disease is prevalent in people who live in the tropics or subtropics; most U.S. patients acquire the disease overseas, the agency said.
“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The labeling for Impavido includes a boxed warning alerting patients and healthcare professionals that the drug can cause fetal harm and shouldn’t be given to pregnant women. Healthcare professionals should advise women to use effective contraception during and for five months after Impavido therapy, the agency noted. Common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated liver enzymes (transaminases) and creatinine.
Impavido is manufactured by Paladin Therapeutics, which is based in Montreal, Canada.
Purdue Pharma to file NDA for abuse deterrent formulation of hydrocodone bitartrate
STAMFORD, Conn. — Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo.
This investigational single‐entity opioid analgesic formulation incorporates abuse deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse by various routes of administration (e.g., snorting and intravenous injection).
“We are very encouraged by the results of this pivotal study,” stated Gary Stiles, Purdue Pharma SVP research and development. “This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers.”
In the study, the majority of patients treated with hydrocodone bitartrate dosed once‐daily experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate.
In addition to this safety and efficacy study, Purdue Pharma has conducted a series of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies with this investigational medication. The company plans to file a New Drug Application with the FDA later in 2014 requesting approval to market the medication.
Currently available hydrocodone formulations do not incorporate abuse‐deterrent technologies, Purdue Pharma noted.