Content about New Drug Application

August 23, 2011

The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

August 4, 2011

GlaxoSmithKline company Stiefel announced it is seeking approval for a facial acne treatment in patients ages 12 years and older.

August 1, 2011

The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

June 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

March 22, 2011

Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

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