New Medicines

From Shire Pharmaceuticals Group plc:


13 Dec 2004 - Basingstoke, UK and Philadelphia, US 13 December 2004 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that the US Food & Drug Administration (FDA) has approved EQUETRO (extended-release carbamazepine capsules), previously known as SPD417, for the treatment of patients with Bipolar Disorder, ten months after submission.


Bipolar Disorder is one of the six leading mental disorders worldwide, according to the World Health Organization. Each year, it is estimated that more than 2 million American adults, about 1 percent of the population age 18 and older, are afflicted with Bipolar Disorder, also known as manic depression. Of the 750,000 currently diagnosed, about 650,000 are treated. The bipolar market in the United States is currently valued at about $1.9bn and is expected to grow to $2.4bn by 2007.


Bipolar Disorder is characterized by episodes of mania and depression, with periods of normal mood in between. The disorder can have devastating effects on an individual’s life, although proper diagnosis and earlier treatment can usually alter the course of the illness.


EQUETRO significantly reduces the manic symptoms in Bipolar patients. Additionally, in clinical trials, patients treated with the product demonstrated no clinically significant weight gain or increase in blood glucose levels, thereby creating an effective tolerability profile. The unique three-bead extended release delivery system of Equetro provides for convenient administration as well. Available in 100, 200 and 300mg dosage strengths, it is the only carbamazepine formulation proven effective for patients with Bipolar Disorder.


Pill Identification - EQUETRO (carbamazepine extended-release):


100 mg-Two-piece hard gelatin capsule yellow opaque cap with bluish green opaque body printed with SPD 417 on one end, SPD417 100 mg on the other in white ink


200 mg-Two-piece hard gelatin capsule yellow opaque cap with blue opaque body printed with SPD 417 on one end and SPD417 200 mg on the other in white ink


300 mg-Two-piece hard gelatin capsule yellow opaque cap with blue body printed with SPD 417 on one end and SPD417 300 mg on the other in white ink.


Updated 03-08-06

From Forest Laboratories:

NEW YORK – November 19, 2004 – Forest Laboratories, Inc. (NYSE: FRX) today announced that Combunox™ (Oxycodone HCl and Ibuprofen) Tablets (CII), the first and only fixed-dose combination of the opioid oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (400 mg), was approved by the U.S. Food and Drug Administration (FDA) for the short-term management of acute, moderate to severe pain. Forest expects to make Combunox available in the U.S. early next year.

Complete press release and prescribing information can be found at Combunox

Pill Identification - COMBUNOX:

Each combination Combunox™ tablet contains:

Oxycodone HCl, USP 5 mg and Ibuprofen, USP 400 mg

Combunox are capsule shaped, white to off-white, film-coated tablets with "F" bisect "P" on one side and "5400" on the other side - FP 5400

From Novartis Pharma AG:

December 23, 2004 – Novartis Pharma AG announced that the U.S. Food and Drug Administration (FDA) has approved Enablex (darifenacin) extended-release tablets (7.5mg and 15mg) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. Enablex, a once-daily medication, is expected to launch in the U.S. in early 2005.

Complete press release can be found at Novartis

Prescribing information is available at Enablex


Pill Identification - Enablex (darifenacin):


The 7.5-mg tablet is round and white-colored with DF on one side and 7.5 on the other side.


The 15-mg tablet is round and peach-colored with DF on one side and 15 on the other side.


For more information, please see the Enablex website.


Updated 03-08-06

From GlaxoSmithKline and Yamanouchi:

VESIcare® (solifenacin succinate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence. In clinical studies, Vesicare 5 mg and 10 mg showed clinical and statistical improvements in all symptoms of OAB. Specifically, once-daily Vesicare was found to significantly reduce the number of incontinence episodes for patients during a 12-week study period.

Complete press release and prescribing information can be found at: http://www.vesicare.com/

FDA approval November 2004


Pill Identification - VESIcare (solifenacin succinate):


5 mg - Round, light yellow tablet debossed with Yamanouchi logo 150


10 mg - Round, light pink tablet debossed with Yamanouchi logo 151


For more information, please see the VESIcare website.


Updated 03-08-06

From Sepracor Inc.

Lunesta (eszopiclone), a new non-narcotic prescription sleep aid from Sepracor, received FDA approval on December 15, 2004. Lunesta represents a new treatment option for those suffering from insomnia; Lunesta not only helps people fall asleep quickly, it helps them sleep restfully through the night, with fewer interruptions, and wake up refreshed and ready to start the day. While current sleeping aids are generally limited to seven to 10 days of use, Lunesta is the first and only prescription sleep aid not limited to short-term use. Physicians can prescribe Lunesta for as long as they determine their patients may need it.

Lunesta will be available in pharmacies mid-January.

Complete press release and prescribing information can be found at the Lunesta Website.

Pill Identification - LUNESTA (eszopiclone):


1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S 190 on one side.


2 mg tablets are round, white, film-coated, and identified with debossed markings of S 191 on one side.


3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S 193 on one side.


Updated 03-04-06

From Purdue Pharma:

The U.S. Food and Drug Administration (FDA) has approved Palladone™ (hydromorphone HCl extended-release) Capsules (CII) for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. The painful conditions may arise from either cancer or non-cancer conditions. While long-acting (q12h) hydromorphone formulations are available in Canada, the United Kingdom, and Germany, Palladone is the first long-acting hydromorphone formulation available in the U.S. The product offers the convenience of once-daily (q24h) dosing and will be available in 12 mg, 16 mg, 24 mg, and 32 mg dosage strengths. Palladone Capsules are expected to be available in retail pharmacies in the first half of 2005.