Content about Lupin III

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.

June 5, 2012

The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

The Mumbai, India-based drug maker announced the approval of Suprax (cefixime) capsules in the 400-mg strength and plans to start shipping the drug "in the near future." The new approval adds to existing suspensions containing 100 mg per 5 mL and 200 mg per 5 mL.

The drug is used to treat infections such as pneumonia, gonorrhea and others.

October 11, 2011

Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

NEW YORK — Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

Dow Jones reported that Lupin launched an authorized generic of Femcon (norethindrone and ethinyl estradiol tablets, ferrous fumarate tablets).

An authorized generic is a branded drug sold under its generic name at a reduced price, usually through a third-party company.

 

April 6, 2011

Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

RALEIGH, N.C. — Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

Under the deal, Salix will receive exclusive worldwide rights for Xifaxan (rifaximin) drug technology developed by Lupin and jointly by both companies in all countries except India.

Salix is required to pay Lupin $10 million upfront, as well as potential payments related to regulatory milestones.

October 12, 2010

Lupin Pharmaceuticals received regulatory approval last week for its generic antihypertensive agents, the drug maker...

BALTIMORE, Md. Lupin Pharmaceuticals received regulatory approval last week for its generic antihypertensive agents, the drug maker said.

Lupin was granted final approval for hydrochlorothiazide-losartan potassium and losartan potassium, the generic versions of Merck's Hyzaar and Cozaar.

Hyzaar and Cozaar had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data for the 12 months ended in June.

May 25, 2010

Lupin Pharmaceuticals has promoted Dave Berthold to head of sales for generics, according to an...