Lamictal XR receives FDA approval as monotherapy
RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.
GSK announced the approval of Lamictal XR (lamotrigine) extended-release tablets as a single-drug therapy, also known as a monotherapy, in epileptic patients ages 13 years and older with partial-onset seizures already taking a single drug and interested in switching over. However, the company said the safety of starting off with Lamictal XR as a monotherapy or switching to the drug as a monotherapy after taking two or more anti-epileptic drugs had not been established. The drug already is approved as an add-on treatment.
“We are committed to providing new and effective treatment options for patients,” GSK SVP neurosciences medicines development center Atul Pande said.
AP Pharma announces financing, appoints new executives
REDWOOD CITY, Calif. — Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.
AP announced the appointment of John Whelan as president, CEO and director, and Michael Adam as SVP and COO.
It also entered into agreements with investors, including Tang Capital Partners, for a private placement of up to $4.5 million in convertible notes. Upon the closing, which is expected to happen Friday, the company will receive $1.5 million. AP plans to put the money toward winning Food and Drug Administration approval for AP530 (granisetron), a drug for treating chemotherapy-induced nausea and vomiting.
AstraZeneca’s thyroid cancer drug launches
WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.
The drug maker announced Monday that the drug would be available to patients with medullary thyroid cancer that could not be removed surgically or that had spread to other parts of the body. The Food and Drug Administration approved the drug on April 6, and it is available exclusively through the pharmacy business unit of Biologics Inc., an integrated cancer management company.
“Vandetanib is the only medicine specifically approved for patients with this rare form of cancer,” AstraZeneca VP specialty care Lisa Schoenberg said. “We believe vandetanib will be important for the community of patients and doctors who are fighting this disease.”