Industry orgs respond to PDUFA reauthorization letter
SILVER SPRING, Md. and WASHINGTON — The Food and Drug Administration on Friday released a document containing details — procedures and performance goals — for the Prescription Drug User Fee Act (PDUFA) reauthorization, or PDUFA VI.
The letter contains provisions that facilitate the integration of patient perspective into the development and review of medications; enhance the FDA’s access to tools and expertise necessary to keep pace with advances in drug development and regulation; help accelerate development and availability of new medicines while providing a regulatory predictability that fosters continued innovation; and ensure that the FDA can hire and retain a workforce that advances its public health mission.
“For nearly 25 years, PDUFA has helped bring innovative medicines to patients by providing greater consistency, certainty and predictability in the U.S. drug review process,” Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen Ubl said. “PDUFA VI will play a critical role as we continue working together to help patients live longer, healthier lives. With the successful conclusion of the PDUFA VI technical negotiations between the FDA and the biopharmaceutical industry, PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and all stakeholders to ensure timely reauthorization of this important program."
The Biotechnology Innovation Organization (BIO) also commented on the letter:
“PDUFA VI resources, together with FDA commitments to achieve greater efficiency in hiring as well as to increase financial stability and sustainability, will provide the agency with the expertise, tools, and resources it needs to effectively perform its vital mission,” BIO president and CEO Jim Greenwood said. “We are especially pleased by the steps that will be taken in PDUFA VI to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions.”
Dr. Reddy’s launches generic Zegerid
HYDERABAD, India and PRINCETON, N.J. — Dr. Reddy’s Laboratories on Monday announced the launch of its generic Zegerid (omeprazole/sodium bicarbonate).
The drug had U.S. sales of about $306.7 million for the 12 months ended May 2016, according to IMS Health. Dr. Reddy’s generic will be available in two dosage strengths: 20 mg omeprazole/1100 mg sodium bicarbonate and 40 mg omeprazole/1100 mg sodium bicarbonate.
FDA expands Prezista indication
SILVER SPRING, Md. — The Food and Drug Administration has approved a bew indication for Janssen Therapeutics’ Prezista (darunavir), the company announced Monday. Prezista, a treatment for HIV-1 in adults and children older than 3 years of age, can now be used by pregnant women with HIV.
“Many HIV treatments have limited data available to support their use during pregnancy,” Janseen Therapeutics VP medica affairs Richard Nettles said. “This expansion of our label is an important advancement in addressing the needs of women living with HIV, and it demonstrates that Prezista is a safe and effective treatment for pregnant women living with this disease. We are proud to be able to provide an option for physicians and mothers who are trying to determine the best approach for HIV treatment.”
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