December 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

 
December 2, 2014

Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for diclofenac sodium topical solution 1.5% w/w.

November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

November 17, 2014

Thirty years ago, Democratic and Republican members of Congress hammered out a rare and prescient bipartisan compromise bill that transformed the pharmaceutical landscape forever and unleashed the modern generic drug industry. That law, known as the Hatch-Waxman Act, has proven to be one of the most far-reaching and impactful pieces of legislation ever to shape the American healthcare system.

November 10, 2014

Sandoz last week announced the launch of a generic version of cyclophosphamide injection, USP. Sandoz is launching the drug through collaboration with Jiangsu Hengrui Medicine Co., which owns the product's abbreviated new drug application. 

October 15, 2014

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

October 15, 2014

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 2, 2014

On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.

June 17, 2014

Novartis on Tuesday announced that it had submitted a biologic license application to the Food and Drug Administration for marketing approval for the use of Bexsero.

June 13, 2014

Teva Pharmaceutical Industries on Thursday announced that the U.S. Court of Appeals for the Federal Circuit upheld a ruling by the U.S. District Court for the District of Delaware finding Bristol-Myers Squibb's entecavir compound claim of U.S. Patent No. 5,206,244 invalid.

June 12, 2014

Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.

June 9, 2014

BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII).

June 2, 2014

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

May 29, 2014

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.

May 28, 2014

Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.

May 28, 2014

Taro Pharmaceutical Industries posted a net sales increase of 13.2% to $759.3 million for its fiscal year ended March 31.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 12, 2014

Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro. The drug is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants.

April 28, 2014

Sandoz on Monday announced the introduction of its adapalene 0.3% gel, a generic version of Differin gel, 0.3% from Galderma Labs.

March 21, 2014

Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).