Perrigo approved for generic Prandin
DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.
"This approval shows the talent and expertise of our R&D and regulatory affairs departments. This is another example of Perrigo’s commitment to bring new products to market and deliver on our mission to provide quality, affordable health care to consumers," said Joseph C. Papa, Perrigo’s Chairman, president and CEO.
Prandin is used to improve glycemic control in adults with Type 2 diabetes. Annuals sales of Prandin tablets are approximately $250 million, according to Symphony Health Solutions.
Hi-Tech Pharmacal gets approval for bromfenac
AMITYVILLE, N.Y. — Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, on Thursday announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day), a generic version of ISTA Pharmaceuticals’ Bromday ophthalmic solution, 0.09%.
The product is used to treat post-op inflammation and reduction of ocular pain in patients who have had cataract surgery. The company plans to launch the product immediately.
Mylan launches generic version of Prandin
PITTSBURGH — Mylan on Thursday announced that its subsidiary has launched repaglinide tablets, a generic version of Novo Nordisk’s Prandin. The drug is used to improve glycemic control in adults with Type 2 diabetes mellitus.
Repaglinide tablets in 0.5 mg, 1 mg and 2 mg had sales in the United States of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.