Caraco Pharmaceutical Laboratories, Ltd. announced that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application (ANDA) for Baclofen tablets.
Caraco's Baclofen tablet is a muscle relaxant and antispastic. It is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Caraco has two strengths available, 10 mg and 20 mg tablets.
Daniel H Movens, Caraco's chief executive officer, said, "We are pleased the FDA granted us another swift approval during this quarter, adding value to our portfolio of products we market in the US. This approval marks the third approval in the current quarter, two within the last 30 days. We continue to work towards expanding our product line as quickly and effectively as possible adding measurable value as we go. We plan to launch this product to the market immediately." This approval brings our total marketed product selection to 23 different products represented by 49 strengths," he added.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription pharmaceuticals to the nation's wholesalers, distributors, drugstore chains and managed care providers.