Court orders Teva to pull generic Pulmicort Respules
JERUSALEM The day after Teva announced that it would begin selling a generic version of AstraZeneca’s asthma treatment Pulmicort Respules, a court issued an order to stop it.
Teva announced the launch of generic budesonide Wednesday. On Thursday, the Israel-based generic drug maker said the United States District Court for the District of New Jersey had granted AstraZeneca’s request for a temporary order restraining further sales of the generic version.
Under the ruling, AstraZeneca and partner Par Pharmaceuticals must also suspend sales of AstraZeneca’s authorized generic version of Pulmicort Respules. A preliminary injunction hearing is scheduled to begin Nov. 25. A trial has been scheduled for Jan. 12.
FDA, SciClone meet agreement on distribution of melanoma treatment
NEW YORK The Food and Drug Administration has reached an agreement with a drug maker on the design of a phase 3 trial of a skin cancer drug.
SciClone Pharmaceuticals announced Monday that it had reached the agreement with the agency concerning the drug thymalfasin, which it sees as a potential treatment for stage 4 melanoma.
“Patients suffering from stage 4 melanoma have very few treatment options available,” SciClone chief medical officer Israel Rios said in a statement. “Based on the positive data from an earlier phase 2 trial, thymalfasin could provide new treatment modalities for this high unmet medical need.”
The drug, if approved, will be sold under the brand name Zadaxin. The full name of its active ingredient is thymosin alpha 1.
Teva releases generic version of AstraZeneca’s Pulmicort
NORTH WALES, Pa. The world’s largest maker of generic drugs has introduced a generic version of AstraZeneca’s Pulmicort Respules.
Teva announced Wednesday that it had launched budesonide inhalation suspension, a treatment for asthma, in 0.25-mg-per-2-milliliters and 0.5-mg-per-2-milliliter strengths.