Specialty Pharmacy

MUMBAI and BALTIMORE — Lupin on Wednesday announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150 mg — a generic version of Pharmacia and Upjohn Company's Mycobutin capsules. The company's U.S. subsidiary will begin marketing the product soon.

The drug is used for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. Mycobutin capsules had annual sales of $18.6 million in the United States, according to IMS MAT.

SILVER SPRING, Md. — The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, which is a condition associated with a lack of fat tissue.

PHOENIX — As part of a study conducted with the University of Arizona, Avella Specialty Pharmacy proved the value of pharmacist intervention in improving patient outcomes, at least in renal transplant patients, to the tune of $27,852 per month, Avella announced Thursday. The study found that participants in the intervention group had a statistically significant improvement in adherence rates over patients in the control group who did not have a contract or receive support to ensure adherence to their monthly medication therapy.

WASHINGTON — In most exchange plans, consumers will face paying a percentage of the costs — often called co-insurance — rather than fixed-dollar co-payments for many specialty medications used to treat rare and complex diseases. According to a new Avalere Health analysis, some plans require enrollees to pay 50% of the specialty drug’s cost. If exchange plans use coinsurance for specialty medications, patients may incur several thousands of dollars of cost-sharing for high-cost drugs before reaching the out-of-pocket maximum.

NEW YORK — The Food and Drug Administration recently approved two "robotic pills," or pills that place an image camera or ingestible sensors into the gastrointestinal tract, according to a report published earlier this week by the Wall Street Journal. 

Other robotic pills still in development include one backed by Google — a pill that would replace injectable drugs, the report noted. 

SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

NOH is a rare, chronic drop in blood pressure upon standing that's associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

FLINT, Mich. — The N.E.W. Life Center, a Flint-based ministry supported by Diplomat Pharmacy, on Tuesday expanded its facility, the specialty retailer announced. 

The community program is based out of the former St. Luke’s Catholic Church on Lawndale Avenue. N.E.W. Life Center founded N.E.W. Life Enterprises, a business that produces scrubs and hospital gowns for use in medical facilities along with other sewn items. The renovation and expansion will house work stations for the seamstresses.

WASHINGTON — The results of the 2013 BPS specialty certification and recertification exams were announced Tuesday by the Board of Pharmacy Specialties, the post-licensure certification organization serving the pharmacy profession.