New Drug Application News and Research

RSS

Barr Pharmaceuticals receives Notice of Allowance for Seasonale patent

Barr Pharmaceuticals has announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for the reissuance of U.S. Patent 5,895,032 ('032), relating to Barr's SEASONALE extended-cycle oral contraceptive.

10 Apr 2007

Pharmacyclics undergoes 'file over protest' for Xcytrin NDA

Pharmacyclics, Inc. has announced its request to the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) for Xcytrin (motexafin gadolinium) Injection be filed over protest.

5 Apr 2007

Genelabs Tech reaches agreement with FDA on special protocol assessment for phase III trial of Prestara in lupus

Genelabs Technologies has announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase III clinical trial of Prestara (prasterone) for treatment of systemic lupus erythematosus (lupus).

4 Apr 2007

Cephalon provides update on Nuvigil NDA

Cephalon has announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).

2 Apr 2007

Study results on bifeprunox in patients with schizophrenia

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week.

2 Apr 2007

Withdrawal of Pergolide products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves.

29 Mar 2007

Two novel therapies for multiple myeloma

Two novel biologics are currently being investigated for their potential benefit to multiple myeloma patients in separate ongoing clinical trials at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

14 Mar 2007

Roche files NDA for pediatric Tamiflu capsules

Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) to market Tamiflu (oseltamivir phosphate) capsules in pediatric doses of 30 mg and 45 mg.

12 Mar 2007

Allowing greater access to drug safety data would enable researchers to better evaluate risks

For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products.

8 Mar 2007

PPD licenses dyslipidemia statin from Ranbaxy

Ranbaxy Laboratories and PPD, Inc. have announced that PPD has acquired an exclusive worldwide license to develop, manufacture and market Ranbaxy's novel statin for the treatment of dyslipidemia.

27 Feb 2007

Maraviroc to receive accelerated review in U.S. and Europe

Pfizer announced today that marketing authorization applications for maraviroc will receive accelerated review in both the United States and Europe. Accelerated reviews are granted to potential medicines that, if approved, would represent significant improvements over current therapies.

13 Feb 2007

FDA approves Neuren's phase 3 Glypromate trial

Neuren Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) and authorised the Company to proceed with its Phase 3 trial to prevent cognitive impairment following major cardiac surgery using Glypromate.

30 Jan 2007