PHARMACY

Mylan subsidiary gets approval for HIV generic under PEPFAR

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved a generic drug for HIV made by a subsidiary of Mylan under a program that supplies drugs to people living with HIV in developing countries, Mylan said Tuesday.

 

The FDA approved Matrix Labs’ atazanavir sulfate capsules in the 150-mg and 300-mg strengths. The drug is a generic version of Bristol-Myers Squibb’s Reyataz. The FDA approved the generic version under the President’s Emergency Program for AIDS Relief, or PEPFAR, which allows Mylan’s product to be distributed in certain developing countries, but not in the United States.

 

 

“This approval is yet another step in improving access to quality, affordable treatment for people living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said. “Atazanavir has a distinct resistance profile compared with other protease inhibitors and is an important addition to the product portfolio being made available to patients in developing countries.”

 

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J&J receives complete response letter for tapentadol ER

BY Alaric DeArment

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

 

The drug maker said the FDA issued a complete response letter for tapentadol extended-release tablets. The agency is requesting data concerning the conversion of the extended-release formulation of the drug used in clinical trials to a different formulation designed to increase the drug’s resistance to breaking or crushing by drug abusers. The FDA issues a complete response letter when it needs more data before it can approve a drug.

 

 

“We will engage the FDA in active discussions as quickly as possible so that we can address the requests in the complete response letter,” Johnson & Johnson pharmaceutical research and development therapeutic area head for analgesia Juergen Haeussler said. “We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible.”

 

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NCPA to HHS: Ensure patients’ access to pharmacies, enforce transparency rules for PBMs

BY Alaric DeArment

ALEXANDRIA, Va. The lobby for the country’s independent pharmacies is urging the Department of Health and Human Services to ensure patients’ access to community pharmacies and enforce transparency rules for pharmacy benefit managers.

The National Community Pharmacists Association said Monday that it had asked HHS to adopt minimum pharmacy access standards in healthcare insurance exchanges. The NCPA also argued against tiered co-payments that favor one pharmacy provider, such as mail order, over others, and argued in favor of allowing any pharmacy willing to accept the terms of the pharmacy contract to participate.

The healthcare-reform law requires PBMs operating in the health-insurance exchanges to confidentially report such information as the percentage of all prescriptions provided through retail pharmacies compared with mail order, and the generic dispensing and substitution rates of each; the aggregate amount and types of rebates, discounts and price concessions that the PBM negotiates on behalf of the plan and the aggregate amount passed on to the plan sponsor; and the average aggregate difference between the amount the plan pays the PBM and the amount the PBM pays the retail and mail-order pharmacy.

“Access to this critical information will enable the [HHS secretary] and the health plans to better evaluate and, in turn, negotiate contracts for prescription drug benefit administration in order to contain costs and maximize consumer protections,” the NCPA said in its comments to HHS. “To date, there has been no clear direction as to where these new federal PBM discloser requirements should be included.”

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