NewsBytes — Chain Pharmacy, 10/15/12
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.
NCPA survey challenges MAC, audits
Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Sept. 18 by the National Community Pharmacists Association.
NCPA polled more than 350 community pharmacists about their recent experience with audits conducted by pharmacy benefit managers and other Medicare Part D plan intermediaries. The survey also asked about generic drug reimbursement caps known as maximum allowable costs, or MACs.
Among the findings:
96% stated that a typical PBM contract has minimal or no transparency on how generic pricing is determined or what the reimbursement rate will be;
Almost 50% of respondents said that more than 10% of the time, PBMs set MAC reimbursement for generics below the pharmacy’s cost of simply acquiring the drug, much less dispensing and overhead costs, and 92% said payments are not increased promptly to reflect a drug’s rising market costs;
3-in-4 pharmacists said audit requirements across Medicare Part D plans are not consistent, increasing their compliance burden; and
Nearly 87% stated that PBM reimbursement and auditing practices are “significantly” or “very significantly” affecting their ability to provide patient care and remain in business.
When asked which drugs had MAC limits set below the pharmacy’s cost of acquiring the product, more than 600 drugs were identified, including budesonide (for asthma); atorvastatin (cholesterol); clarithromycin (antibiotic); fentanyl patches (pain); hydrocodone (pain/inflammation); and methylprednisolone (steroid for allergic reactions, skin conditions and breathing disorders).
ReportersNotebook — Chain Pharmacy, 10/15/12
SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said. The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients ages 6 years and older. The drug maker plans to launch the drug in early 2013. Asthma affects more than 24 million Americans, according to the Centers for Disease Control and Prevention, and healthcare market research firm IMS Health estimated the market for inhaled steroids to be worth $8.3 billion.
Drug maker Vivus has released what it called the first new drug in 13 years for chronic weight management in adults. The company announced the availability of Qsymia (phentermine and topiramate) extended-release capsules, which it is formally introducing to medical professionals at the Obesity Society’s annual scientific meeting in San Antonio. The drug, which is classified as a schedule IV controlled substance by the Drug Enforcement Administration, has a risk evaluation and mitigation strategy, or REMS. In addition to a medication guide, healthcare provider training, patient brochure and other educational materials, the drug is only available through certified mail-order pharmacies that are part of the Qsymia Home Delivery Network, including CVS Pharmacy and Walgreens.
A subsidiary of Johnson & Johnson is hoping to gain FDA approval for a new formulation of one of its drugs. Janssen Biotech announced that it had filed an application with the FDA seeking approval for an intravenous formulation of Simponi (golimumab) in adults with moderately to severely active rheumatoid arthritis, which affects an estimated 1.5 million Americans. The FDA approved the subcutaneously injected formulation of Simponi in April 2009 for moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.