Impax Labs, Tolmar receive FDA approval for generic version of Solaraze
HAYWARD, Calif., and FORT COLLINS, Colo. — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar’s generic version of Solaraze (diclofenac sodium) gel in the 3% strength.
Impax Labs entered into a Development, Supply and Distribution agreement with Tolmar on June 12 in which Tolmar granted Impax Labs an exclusive license to commercialize generic Solaraze in the United States. Under the terms of that agreement, Tolmar is responsible for product development and manufacturing, and Impax Labs is repsonsible for marketing and sales of the product.
Sales of Solaraze gel 3% in the United States were $78 million for the 12 months ended Sept. 2013.
FDA report delves into personalized medicine
SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.
That drug, Vertex Pharmaceuticals’ Kalydeco (ivacaftor), along with cancer drugs for patients whose tumors have specific genetic characteristics identified by a companion diagnostic test, are examples of personalized medicine. Personalized medicine, in which medical treatments are tailored to patients’ individual characteristics, is a growing field and the subject of a new report by the FDA designed to provide a framework for regulating it.
"For the first time, it provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development," FDA commissioner Margaret Hamburg wrote in a forward to the report.
Review supports pharmacogenomic testing for some psychiatric drugs, Assurex Health says
MASON, Ohio — A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients’ response to psychiatric medications and improve treatment outcomes.
Assurex Health said a review published in the International Review of Psychiatry provides "substantial evidence" that pharmacogenomic testing — which is analysis of how patients’ genetic makeup affects their response to drugs — has clinical value in predicting how individual patients will tolerate and respond to specific psychiatric drugs. The review, titled "Clinical Validity of Cytochrome P450 Metabolism and Serotonin Gene Variants in Psychiatric Pharmacotherapy," reviewed published data collected since 2007.
Furthermore, Assurex said, the findings refute results of a previous assessment of pharmacogenomic testing in 2007 by the Evaluation of Genomic Applications in Practice and Prevention initiative, which concluded there was insufficient evidence to determine the value of pharmacogenomic testing for adults starting treatment on certain antidepressants.
"A review of 294 scientific studies published since the EGAPP report clearly demonstrates the clinical validity of multiple genes in predicting patient responses to antidepressant medications," lead study author and Assurex chief science officer C. Anthony Altar said. "This assessment is further supported by multiple clinical trials demonstrating that understanding variations in these same genes leads to better treatment decisions and better patient outcomes."