FDA approves Watson heavy menstrual bleeding drug
PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for heavy menstrual bleeding made by Watson Pharmaceuticals, the drug maker said Thursday.
Watson announced the approval of tranexamic acid tablets through a subsidiary and plans to ship it immediately. The drug is a generic version of Ferring Pharmaceuticals’ Lysteda.
Ferring has filed suit against Watson, alleging that the generic drug infringes two of its patents. Lysteda had sales of about $25 million during the 12-month period that ended in November, according to IMS Health.
Ranbaxy preserves exclusivity period for generic hypertension drug
WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.
Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy’s market exclusivity for a generic version of Novartis’ drug Diovan (valsartan).
Ranbaxy asserted that as the first company to successfully challenge one of the patents covering Diovan, it was entitled to 180 days of market exclusivity in which to compete directly with the branded version, under the Hatch-Waxman Act of 1984, but another company had sought to challenge the exclusivity.
Greenstone launches authorized generic Dilantin Infatabs
PEAPACK, N.J. — Pfizer’s generics division has launched an authorized generic drug for treating epilepsy.
Greenstone announced the introduction of phenytoin tablets in the 50-mg strength, an authorized generic version of Pfizer’s Dilantin Infatabs.
Authorized generics are generic drugs marketed under their generic names at a reduced price, often through third-party companies under contract with the original drug’s manufacturer.