Generic Valtrex to hit the market
NORTH WALES, Pa. Teva Pharmaceuticals has introduced a generic version of a drug for genital herpes, shingles and cold sores, the company said Monday.
Teva announced the introduction of valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug is a generic version of GlaxoSmithKline’s Valtrex.
Valtrex in those two strengths had sales of around $1.8 billion during the 12-month period ended in March 2010, according to IMS Health.
Watson Pharmaceuticals also announced Monday the introduction of its own version of the drug, also in the 500-mg and 1-g strengths.
Genzyme to correct manufacturing quality violations at Mass. plant
SILVER SPRING, Md. Biotech company Genzyme will pay $175 million to the federal government as part of an effort to correct problems at its factory in Allston, Mass., the Food and Drug Administration said Monday.
The FDA announced that Genzyme had signed a consent decree of permanent injunction, agreeing to correct manufacturing quality violations and to adhere to a “strict” timetable to bring the plant in line with regulations. The payment to the government is a disgorgement to make up for profits from drugs made at the factory.
“It is critical for the safety of the drug supply that companies comply with basic manufacturing standards,” FDA principal deputy commissioner Jushua Sharfstein said in a statement. “FDA takes these obligations very seriously and expects manufacturers to do the same.”
During an inspection of the plant between Oct. 8 and Nov. 13, 2009, FDA inspectors found deficiencies in its quality-control systems, leading to shortages and contaminated drugs.
The company is the sole supplier of several enzyme-based biotech drugs used to treat rare genetic disorders. These include Cerezyme (imiglucerase), for Gaucher’s disease, which causes fatty substances to build up around the digestive organs, and Fabrazyme (agalsidase beta), for Fabry disease, which causes oil and fats to build up around the eyes and kidneys, among others.
J&J subsidiaries to pay government for alleged Topamax promotion
BOSTON Two subsidiaries of Johnson & Johnson will pay more than $81 million to the federal government over alleged illegal promotion of an epilepsy drug, the Food and Drug Administration said.
The FDA’s Office of Criminal Investigations announced Friday that Ortho-McNeil Pharmaceutical pleaded guilty in the U.S. District Court in Boston to one misdemeanor violation of the Food, Drug & Cosmetic Act for promoting the epilepsy drug Topamax (topiramate) for uses not approved by the FDA.
U.S. Magistrate-Judge Robert Collings sentenced the company to pay a criminal fine of $6.14 million. Another J&J subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, will pay $75.37 to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and cause false claims to be submitted to government healthcare programs for psychiatric uses that the programs did not cover.
In the case of Ortho-McNeil Pharmaceutical, the company allegedly hired outside physicians to accompany sales representatives on sales calls to healthcare professionals, including psychiatrists, through its “Doctor for a Day Program,” and promoted Topamax for psychiatric uses, even though it had never applied for approval of the drug for treating psychiatric conditions.
“We take the investigation and the settlement very seriously, and we’re fully committed to meeting the requirements of the agreement,” a Ortho-McNeil-Janssen spokesman told Drug Store News.