Generics

LONG BRANCH, N.J. — Francesco International on Tuesday released a Rx-to-OTC projection report covering potential switches through 2016. The potential switches include drugs prescribed for chronic use or for asymptomatic conditions — two switch hurdles that to date have not cleared the Food and Drug Administration approval process.

ANN ARBOR, Mich. — The longer a person maintains a body mass index qualifying him or her as "obese," the greater risk he or she incurs in developing diabetes, a new study released Tuesday found.

SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic skeletal muscle relaxant made by Sagent Pharmaceuticals, Sagent said.

The generic drug maker announced the approval of orphenadrine citrate injection, which it will offer in 60-mg-per-2-mL, single-dose vials.

Various versions of the drug had sales of about $4.3 million in 2011, according to IMS Health.

WASHINGTON — Branded drugs sold under their generic names at a reduced price can reduce retail and wholesale drug prices, according to a new report by the Federal Trade Commission.

The FTC report found that when an authorized generic is introduced onto the market, it can lower the expected profits of the generic drug's manufacturer and, over the longer term, affect generic manufacturers' decisions to challenge patents covering branded drugs with low sales, though patent challenges by generic drug makers "remain robust."

HAMILTON, Ontario — Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

In a study published in the medical journal Gastroenterology, principal investigator John Wallace reported the extent of the hard-to-detect damage caused to the small intestine only recently has been discovered through use of small video cameras swallowed like pills.

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.

NEW YORK — Pfizer and Dr. Reddy's have reached a settlement over the latter's efforts to launch a generic version of the world's top-selling drug, according to published reports.

BALTIMORE — Lupin has received final approval from the Food and Drug Administration for its version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

Lupin said that it received final approval for its abbreviated new drug application for tramadol hydrochloride extended-release tablets in the 100-mg, 200-mg and 300-mg strengths. The drug is a generic version of Ultram ER tablets, which is marketed by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals.