Generics

WASHINGTON — Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

ALLEGAN, Mich. – The Food and Drug Administration has given tentative approval to a generic diabetes drug.

Perrigo Co. announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin, used to treat Type 2 diabetes.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a cholesterol drug made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval of generic fenofibric acid delayed-release capsules in the 45-mg and 135-mg strengths. The drug is used to reduce triglycerides and increase "good" high-density lipoprotein cholesterol.

The drug is a generic version of AbbVie's Trilipix, which has sales of about $554 million per year, according to IMS Health.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries has appointed Dilip Shanghvi as chairman, the Israeli generic drug maker said Thursday.

Taro said James Kedrowski would retire as interim CEO effective Aug. 1, to be replaced by Kalyanasundaram "Kal" Subramanian. Kedrowski will continue to serve as a member of the drug maker's board. Sundaram relinquished his position as chairman to comply with Israeli laws that prohibit a person from simultaneously holding the positions of chairman and CEO; he had served as chairman since April 2012.

PITTSBURGH — A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.

Mylan had filed with the FDA for approval of a generic version of Teva's Copaxone (glatiramer acetate), attracting a patent-infringement suit from Teva alleging that it violated four patents on the drug, according to FDA records. The U.S. District Court for the Southern District of New York has dismissed the case.

PITTSBURGH — Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

Mylan, through its Mylan Pharmaceuticals subsidiary, announced the launch of norethindrone tablets in the 0.35-mg strength. The drug is a generic version of Actavis' Nor-Q.D. tablets, which are taken on a 28-day cycle to prevent pregnancy. Mylan is partnering with Famy Care, which filed for and received Food and Drug Administration approval for the drug.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

The generic drug maker announced that it had received FDA approval for lamotrigine orally disintegrating tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths, a generic version of GlaxoSmithKline's Lamictal ODT.