Impax launches generic Renvela
HAYWARD, Calif. — Specialty pharmaceutical company Impax Laboratories has launched its generic of Renvela (sevelamer carbonate) tablets immediately after receiving Food and Drug Administration approval. The drug is indicated to control serum phosphorus in adults and children ages 6 years and older who have chronic kidney disease and are on dialysis.
“We are pleased to receive approval of our generic version of Renvela," Impax president and CEO Paul Bisaro said. "The immediate launch of this product further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option."
Impax’s generic will be available in 800-mg dosage strength. The product had U.S. sales of approximately $1.9 billion for the 12 months ended August 2017, according to QuntilesIMS data.
The launch follows the recent announcement that Impax would be acquired by Ameal Pharmaceuticals.
Perrigo gets tentative FDA approval for Picato Gel generic
SILVER SPRING, Md. — The Food and Drug Administration has granted tentative approval to Perrigo for its generic of actinic keratosis treatment Picato Gel (ingenol mebutate, 0.015%). The company said that its submission date made it the first to file for a generic of this product.
"This tentative approval illustrates the hard work and dedication of our R&D and regulatory teams as they continue to advance our new product pipeline,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. “The Rx team remains committed to delivering savings for patients and families.”
The drug had U.S. sales of roughly $51 million for the 12 months ended August 2017, according to QuintilesIMS data.
NACDS letter offers Administration, Congress 4 policy solutions to curb opioid abuse
ARLINGTON, Va. — With President Donald Trump set to declare a national opioid emergency this week, the National Association of Chain Drug Stores has suggested four public policy initiatives to the Administration and members of Congress. The suggestions, outlined in a letter sent Tuesday, are aimed at building on current collaborative efforts to stem opioid abuse while maintaining high-quality patient care, NACDS said.
“These four integrated public policy strategies would further reduce the volume of unneeded and unused opioid medications entering the public domain, and reduce the chances that they fall into the wrong hands – while taking into account the needs of those most severely affected by chronic pain as a result of cancer and other serious illnesses,” NACDS president and CEO Steve Anderson said. “The fact that these public policy proposals are gaining traction among those in the healthcare and enforcement communities reflects that much-needed consensus may be starting to build for additional and sound approaches to this epidemic.”
Among the suggestions is a seven-day supply limit for initial opioid prescriptions issued for acute pain — a limit that is in-line with the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain. The letter notes that 20 states have already taken action on this issue, calling for federal legislation to ensure consistent care.
NACDS’ letter also calls for federal legislation mandating electronic prescribing for controlled substances — something that currently only happens for 14% of controlled substance prescriptions. Earlier this year, NACDS voiced its support for the Every Prescription Conveyed Securely Act, which was introduced in August.
The e-prescribing mandate would be one way to enhance security while curbing fraud, waste and abuse. It also would provide a foundation for improving security through a national prescription drug monitoring program that would harmonize varying state requirements for reporting and accessing PDMP data, creating a single system. A national PDMP would use e-prescribing to offer providers and dispensers real-time guidance for patients, NACDS said.
The organization also suggested the use of manufacturer-funded envelopes that patients could use to mail back unused opioids. The envelopes would be available at pharmacies upon request, and their use could be reinforced by a state-legislated mail-back program, NACDS said.
The letter also notes the need to regulate synthetic opioids, the importance of advancing prescriber education tools through the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies for opioids and the need for enhanced treatment for patients with opioid abuse disorders, among other approaches.
“As public health authorities have indicated, face-to-face interactions between pharmacists and patients have made pharmacists keenly aware of the extreme challenges and complexities associated with this epidemic,” Anderson wrote in the letter. “Based on this first-hand experience and our commitment to the patients and communities we serve, NACDS remains steadfast in our efforts to partner with law enforcement agencies, policymakers, and others to work on viable strategies to prevent prescription drug diversion and abuse, including prescription opioids. Chain pharmacies engage daily in activities with the goal of preventing drug diversion and abuse.”