Sun Pharma approved for generic Temodar
MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.
Temozolomide capsules are used for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy. It also serves as a maintenance treatment and for adult patients with refractory anaplastic astrocytomas that have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, according to the company.
Temozolomide capsules are therapeutic equivalents of Merck Sharp & Dohme’s Temodar capsules. The capsules have annual sales of approximately $400 million.
FDA commissioner blogs regarding challenges facing Indian drug manufacturers
SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.
"I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act — reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012," Hamburg reported. "As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs."
Participants of the roundtable meetings last week attended by Hamburg, which were organized by the Federation of Indian Chambers of Commerce and Industries also reported they were challenged by heightened inspectional activities. "I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality," Hamburg said. "I am pleased that as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the United States adhere to established quality standards," she added. "On the home front, we at the FDA also will continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product."
Doxercalciferol now available from Roxane Labs
COLUMBUS, Ohio — Roxane Labs on Tuesday announced the introduction of doxercalciferol capsules, available in strengths of 0.5-mcg, 1-mcg, and 2.5-mcg in 50-count bottles for immediate shipment to wholesalers and pharmacies across the nation.
Doxercalciferol is used to lower elevated parathyroid hormone levels in patients who undergo kidney dialysis. Roxane Labs’ doxercalciferol capsules is AB Rated in the Food and Drug Administration Orange Book to Hectorol (doxercalciferol) capsules, 0.5-mcg, 1-mcg, and 2.5-mcg.
Annual sales of doxercalciferol capsules are approximately $48.7 million.