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FDA News

2/7/12 - FDA Grants Genentechâ??s Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted the companyâ?? s Biologics License Application for pertuzumab and granted Priority Review. The FDA confirmed the action date is June 8, 2012. "We are pleased that the FDA has granted pertuzumab a Priority Review because new medicines are

2/7/12 - FDA grants priority review to Salix treatment

RALEIGH, N.C.-- Salix Pharmaceuticals Ltd. said Tuesday that the Food and Drug Administration granted a priority review to its potential treatment for HIV-associated diarrhea. The Raleigh, N.C., company had submitted the oral treatment, crofelemer, to regulators for review in December. The FDA has set a June 5 target date for making its decision on

2/7/12 - Roche Announces FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for pertuzumab and granted Priority Review. The proposed indication is pertuzumab in combination with Herceptin Â® and docetaxel chemotherapy for people with HER2-positive metastatic or locally.

2/7/12 - Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy

Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration has granted Priority Review designation for the Companyâ?? s New Drug Application for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus/ acquired immune deficienc

2/7/12 - Vyvanse (lisdexamfetamine dimesylate) Capsules, Now Approved in the US for Maintenance Treatment in Adults with ADHD

Shire plc today announced that the US Food and Drug Administration approved the prescription medication Vyvanse Â® Capsules, as a maintenance treatment for adults with ADHD. The approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults who were receiving treatment with Vyvanse for a minim

2/7/12 - Vyvanse(R) (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD

ï»¿Vyvanse, an approved treatment for Attention-Deficit/Hyperactivity Disorder in patients ages 6 and above, is the first medication both proven to work and approved for maintenance treatment in adults with ADHD. Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration approved the prescrip

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