Hi-Tech granted tentative approval for generic Levaquin
AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.
Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.
Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin. Levaquin had sales of $6 million in 2010, according to IMS Health. Levaquin expects to receive final approval in June, when Johnson & Johnson’s patent expires.
Impax, Banner to develop two softgel capsule products
HAYWARD, Calif., and HIGH POINT, N.C. — Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.
Impax said it has entered a deal with Banner Pharmacaps in respect to the supply and commercialization of two softgel capsule products.
The products and terms of the agreement were not disclosed.
Watson faces patent challenge over generic Vigamox
PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.
Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon’s Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.
On Thursday, Alcon and Alcon Research filed suit against the generic drug maker in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of its patents for Vigamox.
Alcon’s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s abbreviated new drug application until Sept. 1, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.