Teva launches generic ADHD drug
NORTH WALES, Pa. – Teva has introduced a generic version of a drug used to treat attention deficit hyperactivity disorder, the company said Thursday.
The drug maker announced the launch of dexmethylphenidate hydrochloride extended-release capsules, a generic version of Novartis’ Focalin XR.
Focalin XR has annual sales of about $202 million, according to IMS Health.
Greatest phase-2, phase-3 drug R&D activity seen in oncology, report finds
BURLINGTON, Mass. — While drug companies are developing treatments for a wide variety of diseases, the greatest amount of mid- to late-stage research and development activity is in cancer treatments, according to a new report.
According to healthcare market research company Decision Resources, among the top 25 drug companies, oncology is the focus for 30% of phase-2 drugs and 22% of phase-3 drugs. Other areas seeing strong activity include drugs for obesity, diabetes, infections and central nervous system disorders.
"To maximize R&D investments, biopharmaceutical companies must continue to address phase-2 and phase-3 attrition and identify better prospects early on," Decision Resources Group SVP Kate Hohenberg said. "As more than half of the costs associated with new drugs are accrued from phase 2 on, this could lead to significant cost savings."
FDA wants more clinical trial data before approving Forest, Gedeon Richter psychiatric drug
NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.
The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug’s efficacy, but wanted more clinical trial data.
"Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug," Forest Research Institute president Marco Taglietti said.