FDA approves Lupin contraceptive
BALTIMORE — The Food and Drug Administration has approved a generic contraceptive drug made by Lupin Pharmaceuticals, the company said Tuesday.
Lupin announced the approval of norgestimate and ethinyl estradiol tablets in the 0.18/0.025-mg, 0.215/0.025-mg and 0.25/0.025-mg strengths.
The drug is a generic version of Ortho Tri-Cyclen Lo, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The branded version of the drug had sales of about $421 million during the 12-month period ended in March, according to IMS Health.
Mylan settles with Sunovion over generic asthma, COPD drug
PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.
Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).
Under the agreement, Mylan can continue to sell a concentrate version of the drug in the 1.25-mg/0.5 mL strength and will have a royalty-bearing license to sell the nonconcentrate version in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths once they receive approval from the Food and Drug Administration. The settlement also releases Mylan from having to pay the $18 million in damages that a grand jury had required it to pay to Sunovion.
FDA panel backs Pfizer drug for rare genetic disease
NEW YORK — An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that the drug tafamidis meglumine would provide certain clinical benefits to patients with transthyretin familial amyloid polyneuropathy, or TTR-FAP, a hereditary disease that affects about 8,000 people worldwide. The FDA is not required to follow the recommendations of FDA advisory committees, but usually does.
The drug has received orphan drug designation, which the FDA gives to drugs that treat conditions affecting fewer than 200,000 people in the United States. Currently, there is no FDA-approved treatment for TTR-FAP.
"The panel’s assessment represents a positive step forward in our goal to provide this much-needed medicine to patients suffering from this rare and fatal disease," Pfizer Specialty Care business unit medicines development group head Yvonne Greenstreet said. "Pfizer will continue to work with the FDA as the agency finalizes its review of our [new drug application] for tafamidis."