Content about Lupin

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

MUMBAI and BALTIMORE — Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths. The product is the generic version of Actos tablets from Takeda Pharmaceuticals.

The drug is used an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Actos tablets had annual sales in the United States of approximately $236 million as of December 2013, according to IMS MAT data. 

 

March 28, 2014

Lupin on Thursday announced the acquisition of 100% equity stake in Laboratorios Grin, subject to certain closing conditions.

BALTIMORE — Lupin on Thursday announced the acquisition of 100% equity stake in Laboratorios Grin, subject to certain closing conditions. The acquisition marks Lupin's foray into the high-growth Mexican and the larger Latin American pharmaceuticals market. Mexico is one of the fastest-growing pharmaceutical markets in the world, valued at more than $13.5 billion and growing at 9% to 10% annually.

March 21, 2014

Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

MUMBAI and BALTIMORE — Pharma Major Lupin announced that Lupin Pharmaceuticals, its U.S. subsidiary, has launched niacin extended-release tablets USP in 500-mg, 750-mg and 1,000-mg strengths.

The drug is the generic version of AbbVie’s Niaspan tablets. It's used to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia, the company said.

March 6, 2014

Lupin on Thursday announced that it received final approval from the Food and Drug Administration for both its doxycycline capsules and its ciprofloxacin for oral suspension.

MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals' Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.

February 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

MUMBAI and BALTIMORE — Lupin on Wednesday announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150 mg — a generic version of Pharmacia and Upjohn Company's Mycobutin capsules. The company's U.S. subsidiary will begin marketing the product soon.

The drug is used for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. Mycobutin capsules had annual sales of $18.6 million in the United States, according to IMS MAT.

 

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy's Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

November 11, 2013

Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

BALTIMORE — Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

Lupin announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $864.3 million during the 12-month period that ended in June, according to IMS Health.

 

October 8, 2013

Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

BALTIMORE — Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.

September 17, 2013

The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

 

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.

July 23, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

Lupin, based in India, received approval for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Santarus' Glumetza.

Glumetza had sales of about $144 million during the 12-month period that ended in March, according to IMS Health. The drug is an extended-release formulation of metformin hydrochloride, a widely prescribed drug used for treating Type 2 diabetes.

 

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

November 21, 2012

Lupin Pharmaceuticals has launched a generic drug for cholesterol disorders, the company said.

BALTIMORE — Lupin Pharmaceuticals has launched a generic drug for cholesterol disorders, the company said.

Lupin announced the launch of fenofibrate tablets in the 48-mg and 145-mg strengths. The drug is used to treat hypercholesterolemia or mixed dyslipidemia and severe hypertriglyceridemia.

The drug is a generic version of Abbott's Tricor, which had sales of $1.26 billion during the 12-month period ended in June, according to IMS Health.

November 15, 2012

The head of Lupin Pharmaceuticals has received an award from accounting firm Ernst & Young.

BALTIMORE — The head of Lupin Pharmaceuticals has received an award from accounting firm Ernst & Young.

Ernst & Young announced Thursday that it had named Lupin CEO Vinita Gupta the inaugural Ernst & Young U.S. 2012 Family Business Award of Excellence winner at its 2012 Strategic Growth Forum in Palm Springs, Calif.

October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

September 13, 2012

The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

BALTIMORE — The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

The Indian drug maker announced the approval of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, used for acute and maintenance treatment of major depressive disorder in adults and adolescents and for acute treatment of general anxiety disorder in adults.

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.

April 23, 2012

Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

PARSIPPANY, N.J. — Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

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.

May 25, 2010

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