Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market cyclobenzaprine hydrocloride tables in 5mg and 10mg strengths. This is Aurobindo's 79th abbreviated new drug application (ANDA) approval from the USFDA.
Cyclobenzaprine hydrocloride tablet is the generic version of McNeil-PPC’s Flexeril tablets 5mg and 10mg and is indicated as an adjunct for relief of muscle spasm, the company said in a press release on Friday.
