According to Lupin, the FDA has approved the company’s ANDA for a generic version of Par Pharmaceutical’s Nascobal single dose cyanocobalamin nasal spray. Lupin said that it will manufacture the nasal spray at its plant in Somerset, NJ, USA.
The FDA approved the NDA for Nascobal single dose nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies in June 2014, and Par launched the product in the US in March 2015. In 2017, Par parent company Endo filed suit against Lupin alleging infringement of patents covering Nascobal after Lupin submitted an ANDA for its generic.
Read the Lupin press release.
