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:6/27/2016)... ... June 27, 2016 , ... ... to revolutionize the emergency ambulance transport experience for the millions of people who ... Uber has disrupted the taxi industry through the use of technology. Now, SmartEMS ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new ... affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... June 23, 2016 The Biotechnology ... continues to present great opportunities to investors. Stock-Callers.com assesses ... Intrexon Corp. (NYSE: XON ), Vertex Pharmaceuticals ... (NASDAQ: ARNA ), and Regeneron Pharmaceuticals Inc. ... stocks and receive your complimentary trade alerts at: ...
Breaking Medicine Technology: