SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product. TIRF drugs include ProStrakan’s Abstral, Cephalon’s Fentora and Actiq, Archimedes Pharma’s Lazanda and Meda Pharmaceuticals’ Onsolis.
Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May. Yanai, who has served in this capacity for five years, has helped Teva expand from a mainly generics business to a more diversified pharmaceutical company, with expected 2012 revenue of approximately $22 billion, and an expanded footprint in the European, Asian and Latin America markets. Yanai will be succeeded by former Bristol-Myers Squibb executive Jeremy Levin. At Bristol-Myers, Levin had direct responsibility for strategy, alliances and transactions, and managed its portfolio of alliances.
The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said. Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.
Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said. Sandoz announced the introduction of clobetasol propionate shampoo in the 0.05% strength, an authorized generic version of Galderma Labs’ Clobex. An authorized generic drug is a branded drug sold under its generic name, usually by a third-party company at a reduced price. Various versions of the shampoo had sales of about $54.9 million during the 12-month period ended in October 2011, according to IMS Health.
The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis. Actavis announced the FDA approval of methylphenidate hydrochloride extended-release capsules in the 20-mg, 30-mg and 40-mg strengths, a generic version of Novartis’s Ritalin LA. Actavis said it was the first to file for regulatory approval of the drug in those three strengths, thus entitling it to 180 days of market exclusivity in which it will directly compete with the branded version. The drug had sales of $80.7 million during the 12-month period ended in September 2011, according to IMS Health.