Specialty Pharmacy

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

SPRINGFIELD, Ill. — A pharmaceutical wholesaler has promoted one of its executives.

H. D. Smith said Harvey Tanenbaum — an industry veteran with more than 30 years of experience — now will serve as the company's EVP, responsible for all efforts connected to metro New York area expansion.

NEW YORK — Pfizer has completed its tender offer for Bristol, Tenn.-based King Pharmaceuticals, Pfizer said Monday.

Pfizer said 230.7 million shares valued at $14.25 each were tendered, representing about 92.5% of King.

Pfizer made its $3.6 billion offer for King in October 2010. The offer cleared the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 on Friday.

NEW YORK — A former Albertsons executive has been named the newest VP pharmacy at ECRM.

Italo Pennella, a licensed pharmacist, will utilize his insight on the pharmaceutical supply chain as ECRM's newest executive. At Albertsons, Pennella's career spanned more than 10 years, which included oversight of all brand manufacturer relationships. Prior to joining ECRM, Pennella most recently served as associated director of trade for Otsuka and Schering-Plough/Organon.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.