Feb. FDA Pipeline

February 1, 2005

New entities and actions in brief

Ventavis

Iloprost

COTHERIX


Lunesta

Eszopiclone

SEPRACOR

FIRST PRESCRIPTION SLEEP AID NOT LIMITED TO SHORT-TERM USE

The effect of this nonbenzodiazepine hypnotic agent is believed to result from its interaction with gamma-amino butyric acid-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. Eszopiclone was approved on December 15, 2004, for the treatment of insomnia.

Cost. According to the manufacturer, the average wholesale price of eszopiclone will be $3.70 per tablet.

FDA Actions in brief Pregabalin (Lyrica, Pfizer) was approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.

FDA approved pegaptanib injection (Macugen, Eyetech/Pfizer) for the treatment of neovascular (wet) age-related macular degeneration.

Darifenacin (Enablex, Novartis) was approved for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

FDA approved paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane, American Pharmaceutical Partners/American Bioscience) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

An oral solution formulation of aripiprazole (Abilify Oral Solution, Bristol-Myers Squibb/Otsuka) was approved by FDA for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar disorder.