Silarx Pharm’s Generic Cyproheptadine Hydrochloride Receives Approval In US
Silarx Pharm’s Generic Levocetirizine Dihydrochloride Receives Approval In US
Silarx Pharms Generic Levocetirizine Dihydrochloride Receives Approval In US
Lannett Company, Inc. (NYSE: LCI) today announced that it received approval last week from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL, the therapeutic equivalent to the reference listed drug, Kaletra® Oral Solution of AbbVie Inc. Lannett, the first applicant to file a substantially complete ANDA for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL with a Paragraph IV certification, may be eligible for 180 days of generic drug marketing exclusivity for the product, although FDA has not made a final determination at this time.
Silarx’s Generic Lopinavir & Ritonavir Receives Approval In US
SilarxI's Generic Memantine HCL Receives Approval In US
Silarx`s Generic Memantine HCl approved in US for Alzheimer`s disease
Lannett Signs Definitive Agreement To Acquire Silarx Pharmaceuticals, Inc.