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Vancocin Generics Launch As FDA Finds ViroPharma’s Label Fails “Significant New Use” Test

 
• By Sue Sutter

FDA delivers an 87-page chef d'oeuvre that concludes the ViroPharma’s long-running battle to block ANDA approvals. In the citizen petition response, FDA rejects the firm’s scientific and legal arguments and concludes the antibiotic is not eligible for three years of Hatch-Waxman marketing exclusivity under a 2008 law. Although ViroPharma says it plans to sue FDA, the company may have bigger problems on its hands with an FTC investigation.

Certain older antibiotics are eligible for three years of Hatch-Waxman marketing exclusivity only if they receive approval for a “significant new use,” not mere labeling refinements of a previously approved indication, FDA said in ending ViroPharma Inc.’s long-running regulatory battle to prevent generic competition to Vancocin (vancomycin) capsules.

In an April 9 citizen petition response, FDA said ViroPharma was not entitled to a three years of marketing protection stemming from a Vancocin sNDA approval on Dec....

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More from United States

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

More from North America

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.