PHARMACY

FDA gives tentative approval to Cipla combo pill for HIV

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

The drug doesn’t currently carry a brand name, and all three active ingredients are available as generics; Apotex and Aurobindo market generic versions of lamivudine, a generic version of ViiV Healthcare’s Epivir, while versions made by several other companies have tentative FDA approval.

A Cipla tablet that combines the three ingredients in the 150-mg, 200-mg and 300-mg strengths, respectively, received tentative approval from the FDA in 2007 and is marketed outside the United States as Duovir N.

Tentative approval means that a drug meets the FDA’s requirements for approval, but the agency can’t allow the manufacturer to launch because of the branded drug’s patent or the market exclusivity period of another company making a generic version hasn’t expired.


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

McKesson Patient Relationship Solutions honored for Lap-Band campaign

BY Michael Johnsen

SCOTTSDALE, Ariz. — McKesson Patient Relationship Solutions earned top honors for patient compliance and adherence programs in both the 2012 Medical Marketing and Media Awards and the PM360 Trailblazer Awards, the company announced Thursday. 

MPRS was honored with a Medical Marketing and Media Award for the company’s Lap-Band Behavioral Call Campaign on behalf of Ogilvy Healthworld. The MM&M Awards are a premier industry event that annually recognizes creativity and marketing effectiveness in health care.  

The Lap-Band Behavioral Call Campaign also recently won the PM360 Trailblazer Award for the Best Direct Marketing to Patient Campaign. McKesson’s LEO Quality Care Program was selected as a finalist for the Best Persistence Campaign Award. Selected by the PM360 editorial board from more than 800 award applications, finalists represent the most forward-thinking leadership of their fields, McKesson noted. 

“We are very pleased that the Lap-Band program was recognized for its creative innovation and proven results by both PM360 and MM&M,” stated Peggy Yelinek, VP and general manager, MPRS. “This continues to validate the importance of personalized conversations that result in meaningful patient interactions to help patients be more engaged with their health.” 

The Lap-Band campaign focused on consumers who had requested initial information about the weight-loss procedure, but had not responded to invitations to attend an informational seminar. Taking the leads generated through DTC efforts, McKesson developed an outreach solution designed to maximize conversion opportunities through live behavioral calls to help guide the consumer through the decision process.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

PharmaSmart teams up with hypertension campaign

BY Alaric DeArment

ROCHESTER, N.Y. — A company that makes health kiosks has joined a campaign to promote blood pressure management among patients with hypertension.

PharmaSmart announced Thursday that it joined the "Team Up. Pressure Down." program, which is part of the Department of Health and Human Services’ Million Hearts initiative, also lead by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services. The program offers such resources as video vignettes and conversation starters designed to encourage and support pharmacists in providing counseling services to patients with high blood pressure. The campaign’s stated goal is to prevent 1 million heart attacks by 2017.

"Together with Team Up. Pressure Down., we offer pharmacies an accredited suite of education and support materials, along with validated clinical tools to aid in hypertension screening, intervention and therapeutic monitoring," PharmaSmart president and CEO Fred Sarkis said. "It’s a very strong partnership for us."

PharmaSmart COO Ashton Maaraba will lead the partnership. The company said it had an existing campaign nationwide to promote validated, pharmacy-based hypertension management as a key element of emerging team care models, and that its representatives were working with healthcare providers and pharmacy retail chains to advance Team Up. Pressure Down.’s message.

"This initiative is an overarching point of differentiation for us," Maaraba said. "It is a clear proof point that PharmaSmart offers a combination of innovative clinical services, biometric screening and health information technology that places the pharmacy — ‘the most profitable center in a retail store’ — in a modern-day power position."


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?