Teva introduces Testim generic
JERUSALEM — Teva on Wednesday announced the introduction of its generic of Testim (testosterone gel, 1%). The company received approval for the generic from the Food and Drug Administration in September.
Teva’s generic is available as 50 mg in a 5-gm tube. The product is indicated for testosterone replacement therapy in adult males for conditions associated with the deficiency or absence of endogenous testosterone. It carries a boxed warning for secondary exposure to testosterone.
CVS Pharmacy offers free medication reviews for inaugural Check Your Meds Day
WOONSOCKET, R.I. — With the inaugural National Check Your Meds Day taking place on Oct. 21, CVS Pharmacy is encouraging its patients to bring their prescriptions medications and supplements to their local location for free medication reviews. The day is being established by Consumer Reports and the Dept. of Health and Human Services.
CVS pharmacists will offer a comprehensive evaluation of the medications they are taking in order to help them better understand their prescription medications, determine whether any of their medications could lead to potentially harmful drug interactions, and help them determine the best time of day to take their prescribed medications to ensure greater efficacy and fewer side effects.
“Medication reviews are an important health care service that our pharmacists provide to patients each and every day," CVS Pharmacy VP pharmacy operations Pete Simmons said. “During these reviews, pharmacists are able to help patients better understand their medications, clear up any confusion that may exist, as well as pinpoint opportunities for cost-savings. It's a great opportunity for patients to take a look at all of their medications and make sure they are taking them correctly.”
Among the factors patients should consider when determining whether or not they need a medication review are the number of prescribers they see, whether they take over-the-counter supplements alongside prescription drugs, if they take multiple medications for one condition or if they take one medication to control the side effects of another. Other factors include cost and whether they have been taking a medication for longer than three months.
CVS Pharmacists bring a unique tool to medication reviews — CVS Pharmacy’s new ScriptPath Prescription Schedule, which is part of its ScriptPath prescription management system. The schedule uses a clinical system that provides a schedule for the most effective time of day to take medications.
With ruling, Restasis could soon face generic competition
MARSHALL, Texas — Allergan’s recent patent claims on its Restasis eye drops were thrown out Monday with a ruling from the United States District Court for the Eastern District of Texas. The 135-page decision found that Allergan’s patent protection for the drug ended in 2014, and that “Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection.”
“While Allergan has pointed to evidence of objective considerations such as commercial success and long-felt unmet need, the force of that evidence is considerably blunted by the fact that, based on protection from a succession of patents, Allergan was able to foreclose competition in cyclosporin/glyceride emulsion formulations from the early 1990s until 2014,” the decision said. “And the issuance of the Restasis patents has barred any direct competition for Restasis since then.”
The lawsuit listed Teva, Mylan and Akorn as co-defendants, all of whom are hoping to market generic versions of Restasis. None of the generic versions have been approved by the Food and Drug Administration, but Mylan CEO Heather Bresch welcomed the decision.
“We couldn't be more pleased with today's federal court ruling invalidating the Restasis patents. For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients,” she said.
Allergan said that the decision was not the end of the road for their intellectual property protection efforts around Restasis.
"We are disappointed by the Federal District Court's decision on the Restasis patents. We are carefully reviewing the decision and are considering all options," Allergan chief legal officer Robert Bailey said. "Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients."