J&J, Merck recall lots of pediatric gas drug due to possible contamination
WASHINGTON The possibility that a drug used to relieve gas in babies contains metal fragments has led to the recall of two lots of the drug, the drug’s manufacturers have announced.
Drug makers Johnson & Johnson and Merck Consumer Pharmaceuticals recalled lots SMF007 and SMF008 of the liquid oral drug Mylicon (simethicone). The lot numbers appear on the bottom of the box and on the sticker of each bottle. The recall affects 1-ounce bottles, but not half-ounce bottles.
FDA raises questions about efficacy of pain medication tamper-proofing
NEW YORK Questions have arisen as to whether a pill by Pain Therapeutics and King Pharmaceuticals is resistant to tampering.
A memo by the Food and Drug Administration Monday concerns the drug Remoxy, a formulation of oxycodone that uses liquid capsule drug-delivery technology designed to prevent misuse of the drug. Some people have abused oxycodone tablets by crushing them, dissolving it in water and then injecting it for its opiate-like effects.
The FDA’s memo said that Pain Therapeutics did not sufficiently conduct long-term tests of Remoxy to determine whether the oxycodone could be extracted and diverted, though Pain Therapeutics disputes that claim.
Titan releases earnings report for Q3 2008
SOUTH SAN FRANCISCO, Calif. Titan Pharmaceuticals has released financial results for third quarter 2008.
Total operating costs for the quarter, which ended Sept. 30, were $6 million, compared with $4.6 million for third quarter 2007, the company said. Net loss for the quarter was $5.9 million, compared to $4.3 million last year; losses in both cases totaled 10 cents a share. The increase in operating costs resulted mostly from an increase in research and development funding related to development of the opiate addiction treatment Probuphine (buprenorphine) and a slight increase in general and administrative costs.
“We have continued to streamline our expenses and focus our resources on the phase 3 clinical development of Probuphine,” Titan president and chief executive Marc Rubin said. “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe, and we are continuing these efforts as we evaluate strategic alternatives for the company.”