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December 11, 2012

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.

December 11, 2012

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.

December 10, 2012

The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

December 7, 2012

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

November 30, 2012

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

November 29, 2012

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

November 29, 2012

A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

November 29, 2012

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012

Some legislators are concerned with the way energy drinks can affect young consumers.

November 28, 2012

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

November 27, 2012

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 19, 2012

The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

November 15, 2012

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


November 14, 2012

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

November 13, 2012

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

November 12, 2012

The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

November 8, 2012

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

November 7, 2012

The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

November 5, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

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