Washington Drug Letter

Lawmakers and watchdog groups are putting a brighter spotlight on the FDA, demanding the agency, HHS and White House take action to ensure whistleblower protections and investigate allegations of inappropriate email monitoring by the drug regulator.

Drug companies’ patent settlements may no longer contain clauses preventing authorized generic (AG) launches after Monday’s landmark court decision on pay-for-delay deals, a pharma lawyer says.

The FDA has green-lighted a new indication for Gilead’s Truvada as the first pill to help prevent HIV infection in high-risk patients.

Sanofi Pasteur has suspended production at its Toronto, Canada, plant to address mold troubles that recently landed the drugmaker an FDA Form 483 and prompted global shortages of a tuberculosis (TB) vaccine and a bladder cancer treatment produced there, the company says.

Compania Internacional de Comercio (CIC), a Mexican maker of OTC topical ointments and gels, has been handed an FDA warning letter for straying from the agency’s good manufacturing practice (GMP) regulations, including failing to document analytical tests and GMP procedures.

The FDA has appointed a former brand-drug industry executive for the long-vacant top spot at Office of Generic Drugs (OGD).

The FTC again is asking for more information from Watson Pharmaceuticals on its proposed $5.6 billion merger with Actavis, delaying its attempt to become the world’s third largest generic-drug company.

The FDA has approved Vivus’ Qsymia, formerly Qnexa, as the second new weight-loss drug in as many months and analysts predict it may take the lion’s share of the anti-obesity market.

GlaxoSmithKline (GSK) and Theravance have submitted applications in the U.S. and European Union (EU) for a new chronic obstructive pulmonary disease (COPD) and asthma treatment.

NuPathe has re-filed its NDA for its Zelrix migraine skin patch with fresh data, hoping to allay performance and packaging concerns that led to a complete response on the company’s first try.

The July 16 issue of Washington Drug Letter contained incorrect information regarding the FDA’s statements about compounded versions of KV Pharmaceuticals pre-term birth drug Makena (hydroxyprogesterone caproate). The FDA said on June 29 it may take enforcement action against compounding pharmacies producing copies of the drug.