Dr. Reddy's launches antibiotics
HYDERABAD, India — Drug maker Dr. Reddy’s Labs has launched a generic antibiotic drug, the company said. The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension. The tablets are being launched in the 500-mg and 875-mg strengths, the capsules are in the 250-mg and 500-mg strengths, and the oral suspension is in the 125-mg-, 200-mg-, 250-mg- and 400-mg-per-5-mL strengths. The drug is a generic version of GlaxoSmithKline’s Amoxil. For the 12-month period ended in June, branded and generic versions of the drug had sales of $22.2 million for the tablets, $67.2 million for the capsules and $89.5 million for the oral suspension, according to IMS Health.
The company also announced the launch of a generic drug for treating high blood pressure, metoprolol succinate extended-release tablets, in the 25-mg, 50-mg, 100-mg and 200-mg strengths. The drug is a generic version of AstraZeneca’s Toprol-XL, branded and generic versions of which had sales of about $1.13 billion during the 12-month period ended June, according to IMS Health.
Depression/anxiety drug approved
BALTIMORE — The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said. 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.
The drug is a generic version of Forest Labs’ Lexapro, which had sales of about $2.7 billion during the 12-month period ended June 2012, according to IMS Health.
FDA approves Lannett
tension headache drug
PHILADELPHIA — The FDA has granted regulatory approval for a generic drug to treat tension headaches. Lannett announced the approval of butalbital, acetaminophen and caffeine tablets in the 50-mg/325-mg/40-mg strength. The drug is a generic version of Watson Pharmaceuticals’ Fioricet. Branded and generic versions of the drug had sales of $30 million during the 12-month period ended in July.
Impax, Teva settle with J&J, Alza over generic ADHD drug
HAYWARD, Calif. — Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder. Impax Labs and Teva Pharmaceuticals USA had settled a patent infringement suit with Janssen Pharmaceuticals and Alza over Concerta (methylphenidate hydrochloride) extended- release tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths. Under the agreement, Impax and Teva will be licensed to sell generic versions of the drug starting July 14, 2013. The two companies are pursuing a strategic alliance agreement with regard to the drug. Branded and generic versions of Concerta had sales of about $1.2 billion during the 12-month period ended in July, according to Wolters Kluwer Health.
Generic ulcer drug approved
PARSIPPANY, N.J. — The FDA has approved a generic ulcer treatment made by Wockhardt, the Indian drug maker said. Wockhardt announced the approval and launch of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths. The drug is a generic version of Prevacid, which Takeda markets in the United States. The drug has a market of about $700 million in the United States, according to IMS Health.
Pfizer, Chinese drug maker
ink branded generics deal
HANGZHOU, China — Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said. Pfizer said it had partnered with Zhejiang Hisun Pharmaceuticals, based in the city of Hangzhou. The partnership, called Hisun-Pfizer, will operate as a joint venture developing, manufacturing and commercializing branded generics, an umbrella term used to describe branded drugs with active pharmaceutical ingredients that have lost patent protection. Hisun-Pfizer has an aggregate investment of $295 million and a registered capital of $250 million, with Hisun owning a 51% share and Pfizer owning 49%, the companies said.