Navigation Links
FDA approves additional dosage strengths of Vyvanse
Date:1/3/2008

PHILADELPHIA January 3, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for three additional dosage strengths for the attention deficit hyperactivity disorder (ADHD) treatment, VYVANSE™ (lisdexamfetamine dimesylate). Shire expects the three additional dosage strengths of 20 mg, 40 mg and 60 mg will be available in retail pharmacies in the second quarter of 2008 to supplement the existing 30 mg, 50 mg and 70 mg dosage strengths currently available in pharmacies throughout the country.

Shire is pleased that physicians will soon have the benefit of a wider range of VYVANSE dosage strengths which they can prescribe to help manage the ADHD symptoms of their patients, said Matt Emmens, Chief Executive Officer of Shire Pharmaceuticals. In its first six months of availability, more than 500,000 VYVANSE prescriptions have been dispensed, indicating that physicians see VYVANSE as an effective treatment option for their patients.

Dose titration, the process of incrementally increasing or decreasing the dose of a medication, is a widely used method in clinical practice to help achieve optimal efficacy and tolerability for each patient. The option of having dosage strengths with smaller increments allows for a more gradual titration of medication and may help the physician tailor the treatment for each individual patient.

Shire has also experienced early success with managed care coverage for VYVANSE, which is now preferred on three of the five largest national plans. According to available national data, more than 85 percent of lives in the United States are covered for VYVANSE in Tier 3 or better, added Emmens. We are optimistic that the formulary coverage for VYVANSE will continue to improve as we move into 2008.

VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the FDA.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.


'/>"/>

Contact: Jacelyn Seng
jacelyn.seng@porternovelli.com
212-601-8385
Porter Novelli
Source:Eurekalert

Related medicine news :

1. FDA approves Bystolic, a novel beta blocker
2. AASM approves home sleep testing to detect sleep apnea
3. HHS Approves Medicaid Waiver to Create New Indiana Health Plan for Uninsured Hoosiers
4. FDA approves ABILIFY(R) (aripiprazole) as the first medication for add-on treatment of MDD
5. ClearWay Minnesota(SM) Board Approves $2.8 Million for Research Grants
6. FDA Approves the Allergy Treatment Zyrtec(R) for Use Without a Prescription
7. FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintenance Dosing
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
9. US FDA approves ABILIFY for adolescent patients with schizophrenia
10. FDA Approves the Opening of a Phase II Registration Protocol Using REXIN-G(R) for Osteosarcoma in California U.S.A.
11. Illinois Planning Board Approves Central DuPage Hospital Bed Pavilion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... ... May 31, 2016 , ... Joe DiMaggio Children’s ... Florida. , The clinic is led by a world class team of ... pediatric neuropsychology and also a team of certified vestibular therapists. , The ...
(Date:5/31/2016)... ... , ... RF Safe's has decades of experience in both RF shielding design ... implicated in the most recent cell phone cancer link released by NTP researchers. , ... 26th (PDF) by the National Toxicology Program (NTP), a multiagency research effort, have ...
(Date:5/31/2016)... Overland Park, Kansas (PRWEB) , ... May 31, ... ... Kansas, announces that Keith Pardoe, FDAI, DAHC, CDC, has joined the Fire Door ... for fire door inspections and fire door and frame in-field re-labeling. He ...
(Date:5/31/2016)... Barbara, CA (PRWEB) , ... May 31, 2016 , ... Throughout the day, adults often ... for sustained motivation and awareness, but what they could be reaching for instead is a ... tea plants that are grown in Japan. This sacred tea is harvested from early June ...
(Date:5/31/2016)... ... 2016 , ... Presence Technology , a multi-channel provider ... Gartner, Inc. in the Contact Center Infrastructure Magic Quadrant (*). , Gartner’s May ... of which include: Computer-telephony integration (CTI)/Web services interfaces, Tools for integration with ...
Breaking Medicine News(10 mins):
(Date:5/31/2016)... England , May 31, 2016 , ... global demand for its Patient Status Engine wireless patient monitoring ... India , Germany , Scotland ... , The company,s 2 nd generation system, launched earlier this ... around the world , , This new technology ...
(Date:5/30/2016)... , May 30, 2016 ... "Healthcare Analytical Testing Services Market by Type (Stability, ... Services), by End User (Pharmaceutical Companies, Medical Device ... MarketsandMarkets, The market witnessed healthy growth during the ... a CAGR of 11.3% between 2016 and 2021 ...
(Date:5/30/2016)... Eye expert s ... examination before leaving hospital ... Moorfields Eye Hospital Dubai, the first overseas branch of the world-renowned ... premature babies as a special concern in the region when it ... of prematurity (ROP). ROP is a potentially blinding condition that affects ...
Breaking Medicine Technology: