January 15, 2014

Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

October 8, 2013

Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

July 26, 2013

Anda VP purchasing Marc Falkin wrote in an email to coworkers and friends that he would begin working for Actavis as VP marketing, pricing and contract operations for the Parsippany, N.J.-based drug maker's generics business.

July 9, 2013

The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

June 20, 2013

Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

February 28, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

February 6, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

January 16, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

January 2, 2013

In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

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.

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 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.


October 29, 2012

Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

August 2, 2012

Big Doctor is watching you — to make sure you're taking your drugs as prescribed, that is.