Content about Generics

ALLEGAN, Mich. — Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market a cinnamon-flavored, over-the-counter coated nicotine polacrilex gum USP in 2-mg and 4-mg strengths.

The product will be marketed under store-brand labels and is comparable with GlaxoSmithKline's Nicorette Cinnamon Surge coated gum, a stop-smoking aid.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal has introduced levofloxacin oral solution in the 25-mg/mL strength, the drug maker said Tuesday.

The drug will be available in 480-mL, 200-mL and 100-mL sizes in order to allow pharmacists to tailor inventory to store volume. Hi-Tech was granted tentative approval in April.

The drug is a generic version of Johnson & Johnson’s pneumonia treament Levaquin.

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.

PITTSBURGH — Generic drug maker Mylan is looking for a bigger place to call home, according to published reports.

The Pittsburgh Business Times reported that Mylan was planning to move from its current 96,000-sq.-ft. headquarters in Southpointe, a development in the Pittsburgh suburb of Cecil Township, to a 250,000-sq.-ft. building nearby.

The new headquarters is under construction, the newspaper reported.

HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

PARSIPPANY, N.J. — Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252. 

Watson stated it is continuing to seek final approval of the products from the Food and Drug Administration. 

SHIRLEY, N.Y. — American Regent has launched a generic drug for relieving pressure inside the eye, the company said.

American Regent announced the availability of latanoprost ophthalmic solution in the 0.005% strength.

The drug is a generic version of Pfizer’s Xalatan and is used to treat such conditions as glaucoma and ocular hypertension.

HYDERABAD, India — Dr. Reddy’s Labs has launched a generic drug for treating high blood pressure, the company said Thursday.

Dr. Reddy’s announced the launch of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths.

The drug is a generic version of Novartis’ Lotrel, which had sales of $290 million during the 12-month period ended in March, according to IMS Health.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.

Net income for Hi-Tech totaled $12.7 million, or 98 cents per diluted share, compared with $6.5 million, or 50 cents per diluted share in fourth quarter 2010.

BRIDGEWATER, N.J. — Chirag Patel and Chintu Patel, who respectively are the president and CEO of Amneal Pharmaceuticals, recently received the Ernst & Young Entrepreneur of the Year award.

The executives received the 2011 New Jersey Award in the pharmaceutical and medical technology category, which was presented at a gala event last month.

WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.