New strength of Intelence gets regulatory approval
TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.
Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.
The recommended dosage of the drug is either 200 mg or two 100-mg tablets; the 100-mg tablets will remain available on the market, Tibotec said. The company expected to launch the 200-mg formulation later this month.
Glenmark gets FDA OK for three drugs
MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.
On Dec. 23, the company announced the approval of the arthritis treatment indomethacin in the 25-mg and 50-mg strengths; sales for the drug were $20 million during the 12-month period ended in September 2010, according to IMS Health. The agency also approved sulfamethoxazole and trimethorprim double- and single-strength tablets, used to treat chronic bronchitis, bacterial infections and other conditions; sales for the drug were $31 million, according to IMS.
In addition, the FDA granted tentative approval for eszopiclone, a generic version of Sepracor’s insomnia treatment Lunesta, which had sales of $760 million, according to IMS. Tentative approval means that a generic drug meets the FDA’s conditions for approval, but the agency must wait to grant final approval until the branded drug loses patent protection.
On Dec. 28, the agency approved the company’s lithium carbonate extended-release tablets in the 300-mg strength. A generic version of Noven Therapeutics’ Lithobid, the drug is used to treat manic episodes in patients with bipolar disorder. Total sales for the drug were $21 million during the 12-month period ended in September 2010, according to IMS.
George W. Bush to deliver keynote speech at Armada summit
FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.
The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.
“We are honored that President Bush will be speaking at our conference,” Armada CEO Lawrence Irene said. “As the largest gathering of industry stakeholders, our annual meeting offers the ideal agenda to gain a valuable insight into the rapidly growing specialty pharmacy channel. One of the highlights of our conference will certainly be the keynote address by [former president] Bush.”