India-based global pharma company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Wednesday that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45mg and 17.8mg.
This product will be manufactured at Lupin's Nagpur facility in India.
The US regulator has tentatively approved Lupin's Pitolisant Tablets 4.45mg and 17.8mg as bioequivalent to Wakix for the indication in the approved labelling.
Wakix is a registered trademark of Bioprojet Europe Ltd. The drug is indicated for the treatment of narcolepsy with or without cataplexy in adults and in children over 6 years of age.
Futura Medical reports positive home user test results for Eroxon and Intense variant
GSK secures Japan Orphan Drug status for lung cancer ADC
Belief BioMed enters exclusive partnership with Grand Life Sciences for haemophilia A treatment
Glaukos launches Epioxa to advance incision-free treatment for keratoconus
Sanofi's venglustat receives FDA Breakthrough Therapy designation for type 3 Gaucher disease
Sentynl Therapeutics and PRG S&T enter licensing agreement for potential HGPS treatment
CMIC agrees agentic AI partnership with Bluenote
Biofrontera reports Phase 2b data for Ameluz photodynamic therapy in acne vulgaris treatment
Precision BioSciences receives FDA Fast Track designation for PBGENE-DMD
Egetis receives US notice of allowance for MCT8 deficiency composition patent
Ipsen withdraws tazverik across all markets following safety concerns in lymphoma trial
Foresee Pharmaceuticals receives positive CHMP opinion for CAMCEVI 21 mg
Great Novel Therapeutics' GNTbm-38 approved by US FDA for Phase I trial