KV subsidiary hydromorphone hydrochloride tablets
ROCKVILLE, Md. A subsidiary of KV Pharmaceutical has recalled a lot of hydromorphone hydrochloride 2 mg tablets due to the possibility of oversized tablets, the Food and Drug Administration announced Tuesday.
Ethex Corporation and the FDA have notified healthcare professionals of the recall. The FDA that the oversized pills may lead to improper dosage, thus increasing the risk of adverse side affects associated with the drug, including difficulty breathing, low blood pressure and sedation.
The recalled tablets are round and blue, with a script “E” on one side and a “2” on the other. The recalled lot number is 90219, with an expiration date of March 2010 and the NDC number 58177-0620-04.
The tablets are a generic version of Purdue Pharma?s Dilaudid and used to treat severe pain.
European Commission approves marketing of Celgene drug
BOUDRY, Switzerland The European Commission has approved the marketing of a cancer drug by Celgene International Sarl, the Swiss biotech company announced Tuesday.
The company described Vidaza (azacitidine) as the first epigenetic cancer therapy to significantly extend survival for patients with intermediate-2 and higher-risk myelodysplastic syndromes and acute myeloid leukemia.
“The European Commission approval of Vidaza is recognition of the significant survival benefited afforded by this therapy for critical hematological malignancies,” Celgene Europe president Philippe Van Holle.
“We will now begin working with local regulatory authorities on a country-by-country basis for reimbursement and distribution for all European Union member states.”
Teva chief confident bill on follow-on biologics to appear in Congress
NEW YORK The chief executive officer of Teva North America is confident that a bill to create a regulatory pathway for follow-on biologics will appear in Congress next year, according to published reports.
Bill Marth, chief executive of Teva Pharmaceutical Industries? North America division, told Reuters Tuesday that there was a “very good chance” that Congress would introduce a bill to allow follow-on biologics, also known as biosimilars, in 2009.
Several large drug makers have already announced plans to create biosimilar divisions, including Merck & Co., Eli Lilly & Co. and AstraZeneca, which announced its own plan earlier this week.