Cocaine HCl Topical Solution is a proprietary local topical anesthetic.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 21, 2018, ten months from the official NDA submission date.
The 505(b) (2) NDA submission is supported by two Phase III, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase I pharmacokinetic study.
Lannett Co, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling
Sandoz's Tyruko (natalizumab-sztn) gains FDA approval as first biosimilar for relapsing MS
Nephron Pharmaceutical names new chief procurement officer
Lupin Pharmaceuticals launches Tiotropium Bromide Inhalation Powder, 18mcg/capsule in US