FDA approves CNS Therapeutics' baclofen injection drug for severe spasticity
December 20th 2010CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
Fingolimod (Gilenya): An oral sphingosine 1-phosphate receptor modulator
December 1st 2010New molecular entity: Fingolimod (Gilenya) has recently been approved by FDA to treat patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Kombiglyze XR tablets approved for the treatment of type 2 diabetes mellitus in adults
November 8th 2010FDA has approved saxagliptin and metformin extended-release (XR) (Kombiglyze XR, AstraZeneca/Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels, fasting plasma glucose, and postprandial glucose
FDA issues complete response letter for lorcaserin
October 25th 2010FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.
FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery
October 21st 2010Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.