New Products

RALEIGH, N.C. — BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII). The drug is used as a maintenance treatment of opioid dependence. The company noted that it also should be used as part of a complete treatment plan to include counseling and psychosocial support.

Bunavail is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration, BDSI said.

WASHINGTON — The Office of the National Coordinator for Health Information Technology last week issued a policy paper, "A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure," which outlines the government's pledge to support interoperable electronic health records to most Americans. 

America is three-quarters of the way there. 

SAN ANTONIO — A new spray being introduced by Mission Pharmacal is offering relief from dermatitis caused by incontinence.

Dr. Smith's Adult Barrier spray is a zinc oxide treatment for rashes and irritation that typically accompanies adult incontinence, which afflicts some 50% of residents in nursing homes. The spray offers an alternative to the lotions and creams that are typically used to treat rash associated with incontinence, with a lower risk of cross-contamination and thus, infection.

PITTSBURGH — Mylan on Monday announced the launch of carboplatin injection, 50-mg/5-ml, in multi-dose vials. The drug is the generic version of Paraplatin injection from Bristol-Myers Squibb.

The company also received final approval for the carboplatin injection 150-mg/15-ml, 450-mg/45-ml and 600-mg/60-ml multi-dose vials, with plans to launch those strengths at a later date.

NEW YORK — Purely Elizabeth, a natural foods company, announced that its line of Ancient Grain Granola debuted at Target stores across the country on June 8. Consumers can choose from original, pumpkin fig and cranberry pecan varieties.  

ORCHARD PARK, N.Y. — Mentholatum Co.’s Softlips brand is now debuting at retail its new Softlips Cube.

The new dome-shaped balm is a 5-in-1 formula that promises to hydrate, replenish, smooth, protect with SPF 15 and add a subtle sheen.

The suggested retail price is $3.49 and comes in new flavors: pomegranate blueberry, fresh mint and vanilla bean.

NORTH WALES, Penn. — Teva Pharmaceuticals announced the launch of Mimvey Lo (estradiol and norethindrone acetate tablets, USP), the generic equivalent to Activella tablets. The drug is used to treat certain symptoms of menopause.

"Our customers count on Teva for a continuous supply of new generic products,” said Maureen Cavanaugh, SVP U.S. Generics Sales & Marketing. “With the launch of Mimvey Lo, we add another quality product to our broad line of affordable generic pharmaceuticals.”

MAPLE GROVE, Minn. - Upsher-Smith Laboratories on Wednesday announced that it has received final approval from the Food and Drug Administration for its new drug application for Vogelxo (testosterone) gel for topical use CIII.  

Vogelxo is a Schedule CIII androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).