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Boots 1-of-7 companies to join CRN

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition on Wednesday announced the addition of seven new companies to its membership roster, including the Boots Co., which joined CRN as an international member. 

The other additions included voting members Arbonne International, Bergstrom Nutrition, HORN Nutraceuticals and SmartyPants, as well as associate members Jones Day and MCS Associates. 

“We are very pleased to welcome seven new companies to the CRN family,” stated Steve Mister, CRN president and CEO. “It is rewarding to see that companies are continuing to recognize the benefits of CRN membership, and we look forward to working with our new members to continue to strengthen a responsible industry.”

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Greer Labs gets FDA approval for Oralair

BY Ryan Chavis

LENOIR, N.C. — Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

Oralair is used for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. It’s approved for people ages 10 years through 65 years.

Traditionally, allergy immunotherapy in the United States has been administered through a series of subcutaneous injections in an allergy specialist’s office. The approval of Oralair provides an additional option for allergy specialists and patients to consider when treating grass allergies.

“We are very pleased with the FDA’s approval of Oralair and believe it will provide a valuable treatment alternative for many patients with grass allergies,” said John G. Roby, Greer president and CEO. “Until now there has not been a sublingual allergy immunotherapy tablet available for grass allergic patients. As part of our dedication to advancing allergy immunotherapy, we look forward to launching Oralair with our partner Stallergenes and bringing this treatment option to patients here in the United States."  

Grass allergies are the most common seasonal allergy in the United States. Oralair is the only FDA-approved oral allergy immunotherapy tablets that includes a five grass, mixed pollens allergen extract, the company said, which provides a wide range of grass allergy coverage. The Oralair tablet dissolves under the tongue; the first dose is taken in the doctor’s office under medical supervision, with subsequent doses administered once a day by the patient or a caregiver.

 

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Sandoz introduces generic version of Leo Pharma’s Taclonex Ointment

BY Michael Johnsen

PRINCETON, N.J. — Sandoz on Tuesday announced the U.S. market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex Ointment.

Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of psoriasis vulgaris in adults 18 years and older.

Psoriasis affects approximately 2% of the U.S. population. Plaque psoriasis is the most common form of the condition. 

"Sandoz is proud to be first-to-market with a generic version of this important therapy,” stated Peter Goldschmidt, president of Sandoz U.S. “This launch further broadens our strong offering of differentiated generic dermatology products.”

Sandoz will market calcipotriene and betamethasone dipropionate through a partnership with Tolmar, which owns the abbreviated new drug application for the product and was the first company to receive FDA approval for a generic version.

According to IMS Health, aggregate U.S. sales for the branded version of calcipotriene and betamethasone dipropionate ointment were approximately $96 million for the 12 months ending December 2013. Sandoz is marketing calcipotriene and betamethasone dipropionate ointment in 60 g and 100 g tubes, the same strengths that are marketed as Taclonex Ointment.

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