Taro resolves FDA warning letter
HAWTHORNE, N.Y. — Taro said that the Food and Drug Administration has declared the drug maker’s manufacturing facility in Canada as having acceptable regulatory status.
The drug maker said it diligently worked to resolve issues noted in an FDA warning letter dated Feb. 5, 2009. The regulatory agency reinspected the manufacturing facility last February.
"We are dedicated to developing and manufacturing quality products for our customers while meeting and exceeding all good manufacturing practices standards set by the FDA and Health Canada," said James Kedrowski, interim CEO for Taro.
Watson joins Walgreens on New Life Agency’s Fertility Pharmacy Care Card
RANCHO MIRAGE, Calif. — The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.
The New Life Agency aligned with Watson Pharmaceuticals to include Crinone (progesterone gel 8%) in the program, which will provide patients with the FPCC with $30 in savings on every Crinone prescription. Patients who purchase the card — which provides infertile patients, egg donors and surrogates a cash-only program with significant discounts on fertility medications — also will get a $100 discount for each $1,000 purchase of stimulation medication through Walgreens Specialty Pharmacy.
Once enrolled, patients will receive a $25 Walgreens gift card usable at any store.
“Our goal is to offer personalized fertility pharmacy services, along with the best possible support, for these very specialized pharmacy needs,” Walgreens Specialty Pharmacy VP product development Enyde Polesuk said. “We’re pleased to be part of this first-of-its-kind cost solution, and look forward to making our services more accessible than ever for hopeful parents-to-be.”
The New Life Agency also is recognizing National Infertility Awareness Week together with RESOLVE.
“[RESOLVE] is delighted that New Life Agency is recognizing National Infertility Awareness Week and applauds their efforts to help educate the American public about resources available to the women and men fighting the disease of infertility,” RESOLVE executive director Barb Collura said.
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.