Generics

SILVER SPRING, Md. — The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

The FDA approved abacavir sulfate tablets in the 300-mg strength made by Apotex and Aurobindo.

The drug is a generic version of Viiv Healthcare's Ziagen.

Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter. 

NEW YORK — Negative perceptions of generic drugs are more likely among blacks and Hispanics, according to a new study.

The study, published in the journal Ethnicity & Disease, found that negative perceptions of generic drugs were more widespread among ethnic minorities than among whites.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is selling its generics business to India-based Sun Pharmaceutical Industries, Takeda said Monday.

Takeda said it would sell URL Pharma, through U.S. subsidiary Takeda Pharmaceuticals USA, to Sun subsidiary Caraco Pharmaceutical Labs while retaining control of the gout treatment Colcrys (colchicine). Takeda acquired rights to Colcrys when it bought URL Pharma for $800 million in June 2012; financial terms of the current deal with Caraco were not disclosed.

WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.

NEW YORK — The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

Politico reported that the justices had agreed to hear three cases, including Federal Trade Commission v. Watson Pharmaceuticals, involving settlements between branded and generic drug companies that critics deride as "pay-for-delay" deals.

ALBANY — The New York Department of Health on Monday announced that reported cases of influenza are increasing throughout New York, and flu activity in the state is now considered to be widespread, with laboratory-confirmed cases in more than half the regions. 

Since New York began its annual seasonal flu surveillance this fall, influenza cases have been reported in 47 counties and the five boroughs of New York City. This is consistent with nationwide reporting that shows influenza activity is also increasing in many regions of the country. 

WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.

Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.

EUGENE, Ore. — The American Heart Association has joined a group of patient and provider organizations promoting safe use of a commonly used class of painkillers.

The AHA announced that it had joined the Alliance for the Rational Use of NSAIDs, which refers to nonsteroidal anti-inflammatory drugs, a class that includes the common drug ibuprofen. Other members include the American Academy of Nurse Practitioners and the American Association of Colleges of Pharmacy.