New Products

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets. 

The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. 

WHITEHOUSE STATION, N.J. — Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use. The drug is an allergen extract used for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. It is approved for use in persons ages 5 years through 65 years of age.

PEAPACK, N.J. — Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products. The drug is the authorized generic versions of Caduet.

GURNEE, Ill. — Quest Products on Friday announced the addition of a gel formulated for emergency burn relief, Alocane Emergency Burn Gel, to its current line of products. Previously a top-selling product on retail shelves in the 80's and 90's, it was taken off the market due to financial difficulties facing the parent company, First Pharmaceutical.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of a generic equivalent to Lunesta (eszopiclone tablets) in 1-,2- and 3-mg form in the United States. The drug is used to treat insomnia.

Lunesta tablets, which are marketed by Sunovion Pharmaceuticals, had annual sales of $852 million in the United States as of December 2013, according to IMS data.

COLUMBIA, Md. — TheraPearl, a creator of therapy products, announced that its line of hot and cold pearl-filled packs will soon be available in Target stores across the country.

The company's Back Wrap and Sports Pack are already available at Target.com and will make their brick-and-mortar debut in the First Aid section on April 19. While TheraPearl's products have been available in Target Canada since last year, this announcement marks the first appearance of its products in Target's U.S. stores.

PITTSBURGH — Mylan announced that it has launched eszopiclone tablets in 1 mg, 2 mg and 3 mg form. The drug — which is used for the treatment of insomnia — is the generic version of Lunesta from Sunovion Pharmaceuticals.

Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application. Eszopiclone tablets had sales in the U.S. of approximately $851.8 million for the 12 months ending Dec 31, 2013, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved Tanzeum (albiglutide) subcutaneous injection, which is used to improve glycemic control in adults with Type 2 diabetes.

Type 2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.