FDA approves Par and Tris Pharma’s generic Tussionex
WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic treatment for cough and upper respiratory symptoms resulting from colds and allergies made by Par Pharmaceutical and Tris Pharma, Par said Tuesday.
The FDA approved hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension. The drug is a generic version of UCB’s Tussionex, which has annual sales of around $226 million, according to IMS Health.
“The introduction of this first-to-market generic product will improve patient access to a much-needed therapy,” Par EVP and president Paul Campanelli said. “Our partner, Tris Pharma, has once again leveraged its innovative drug-delivery platform to bring this important product market.”
J&J receives complete response letter for tapentadol ER
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.”
NCPA to HHS: Ensure patients’ access to pharmacies, enforce transparency rules for PBMs
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.”