Regulatory and Washington

WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.

WASHINGTON — Legislation repealing a requirement that nonprescription medicines would need an accompanying doctor’s prescription in order to qualify for reimbursement from employee-paid flexible spending accounts could be introduced to both Houses as soon as next week, according to a report published Tuesday in the political daily Politico.

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

BASEL, Switzerland — The Food and Drug Administration has approved a Novartis vaccine for preventing meningococcal disease in children, the Swiss drug maker said.

Novartis announced the approval of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization to prevent certain forms of meningococcal disease caused by Neisseria meningitidis in children ages 2 to 10 years. The FDA approved the vaccine last year for use in adolescents and adults ages 11 to 55 years.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


HYDERABAD, India — A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

Dr. Reddy’s said the U.S. District Court of New Jersey had filed a stipulation and order lifting the earlier injunction against the drug maker regarding the selling of a version of fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in the 180-mg/240-mg strength. The drug is a generic version of Sanofi-Aventis’ and Albany Molecular Research’s Allegra-D 24.

PENSACOLA, Fla. — A federal judge in Florida has overturned a key portion of the healthcare-reform law and ruled that the entire law must be scrapped.