Generics

MUMBAI and BALTIMORE — Lupin has launched its generic of Norco (hydrocodone bitartrate and acetaminophen) tablets. The drug is indicated to relieve moderate to moderately severe pain.

Lupin’s generic will be available in dosage strengths of 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. The drug had annual U.S. sales of $710 million for the 12 months ended June 2017, according to QuintilesIMS data.

MAPLE GROVE, Minn. — Upsher-Smith Laboratories has introduced its generic of Aromasin (exemestane) tablets. The drug is an aromatase inhibitor indicated as an adjuvant treatment in postmenopausal women with breast cancer than has been treated with tamoxifen.

HYDERABAD, India, and PRINCETON, N.J. — Dr. Reddy’s Laboratories recently launched its generic of Renvela (sevelamer carbonate) tablets. The drug is indicated to control serum phosphorus in adults and children ages 6 years and older with chronic kidney disease who are on dialysis.

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s generic version of Corgard (nadolol) tablets. The drug is indicated to manage patients with angina pectoris and to treat hypertension.

Lupin’s generic will be available in 20-, 40- and 80-mg dosage strengths. The drug had U.S. sales of $109.8 million for the 12 months ended June 2017, according to QuintilesIMS data.

HERTFORDSHIRE, England, and PITTSBURGH — Just a day after it received approval from the Food and Drug Administration for its generic of Copaxone (glatiramer acetate injection) — both as a 40-mg/mL three-times-a-week treatment and as a 20-mg/ml once-daily injection, the company has launched the drug.

Mylan’s generic was approved with an indication to treat patients with relapsing forms of multiple sclerosis.

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s generic of Acticlate (doxycycline hyclate) tablets. The drug is indicated to treat infections caused by various micro-organisms and as an adjunctive therapy for severe acne.

Lupin’s generic will be available in 75- and 150-mg dosage strengths. The product had U.S. sales of roughly $253 million for the 12 months ended June 2017, according to QuintilesIMS data.

SILVER SPRING, Md. — As it continues to expand on its Drug Competition Action Plan, the Food and Drug Administration has outlined new efforts to make it easier for manufacturers to bring complex generics to market. In a post on the FDA’s blog, commissioner Dr. Scott Gottlieb noted that in many instances complex drugs — which include drugs with complex active ingredients and complex drug-device combination products — do not have generic competitors for various reasons.

HERTFORDSHIRE, England, and PITTSBURGH — Mylan is expanding its offering of oncology generics with its latest introduction. The company has launched its generic of Gleeven (imatinib mesylate) tablets.

The drug is approved to treat multiple indications, including several blood cancers, the company said. The drug had U.S. sales of approximately $1.7 billion for the 12 months ended July 31, according to QunitilesIMS data. The product will be available in 100- and 400-mg dosage strengths.