Greer Labs gets FDA approval for Oralair
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.
Sandoz introduces generic version of Leo Pharma’s Taclonex Ointment
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.
Industry vet Bob Long passes away
WALNUT CREEK, Calif. — Robert M. Long, former president, CEO and chairman of Longs Drug Stores passed away March 27 due to complications, which occurred as a result of inclusion body myositis.
Long was a well-known industry veteran having led Longs Drug Stores for more than 20 years. His retirement from the Walnut Creek, Calif.-based pharmacy retailer as CEO in 2000 marked the first time that a member of the founding family was not heading the company.
Long was elected to the board in 1968 and was elected president of Longs Drugs in 1975. In 1991, he was elected chairman and CEO. The Walnut Creek, Calif.-based pharmacy retailer had grown to 416 stores generating $3.7 billion in sales by 2000 when he relinquished the CEO title. Long continued to serve on the board as chairman from 2000 to 2003 and afterward as chairman emeritus. He stepped down from the board in 2007 at the age of 68.
When announcing Long’s retirement as chairman emeritus in 2007, then chairman, president and CEO of Longs Drug Stores, Warren Bryant said, "We are all very proud that we could open the 500th Longs Drugs and surpass $5 billion in sales before Bob announced his intentions to retire. The board of directors and the employees of Longs Drugs extend our deepest appreciation and gratitude for what Bob has contributed to the company that his father and uncle founded nearly 70 years ago."
In 2008, CVS Caremark acquired Longs Drug Stores, folding into its portfolio Longs’ 521 retail locations in California, Hawaii, Nevada and Arizona, as well as its PBM services. CVS/ pharmacy still operates under the Longs Drug Store banner in Hawaii.
The Long family has not yet finalized plans for a memorial service. Expressions of condolences can be sent to: Office of Robert Long , PO Box 3827, Walnut Creek, Calif., 94598-0827 .
In lieu of flowers, the family would appreciate contributions be made to a charity of your choice.