Content about New Drugs & OTCs

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.

HACKENSACK, N.J. — An organization focused on a fatal genetic disorder that affects men has launched a mobile app that allows for the location of clinical trials and clinics.

WASHINGTON — More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America said 241 medicines were in clinical development or under review by the Food and Drug Administration, including 98 for lymphoma, 97 for leukemia, 52 for multiple myeloma and 24 for malignancies of the bone marrow, blood and lymph nodes.

PEAPACK, N.J. — Greenstone has launched an authorized generic painkiller, the company said.

Greenstone, the generics arm of Pfizer, announced the introduction of authorized generic oxaprozin caplets in the 600 mg strength. The drug is a version of Pfizer's Daypro, a non-steroidal anti-inflammatory drug, or NSAID.

Authorized generics are branded drugs sold under their generic names at a reduced price.

DUBLIN — The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of Minastrin 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for prevention of pregnancy.

The drug maker said an unnamed third-party company would manufacture the drug, but it did not expect to launch it this year.

BASEL, Switzerland — The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

PARSIPPANY, N.J. — A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

LONDON — A Food and Drug Administration panel has recommended that the agency approve an experimental drug for chronic obstructive pulmonary disease made by GlaxoSmithKline and Theravance, the two companies said.

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 9-4 to recommend Breo Ellipta as a long-term maintenance treatment for airflow obstruction in patients with COPD and for reduction of COPD exacerbations in patients with a history of them. The drug is a once-daily inhaler that combines fluticasone furoate and vilanterol.

PRINCETON, N.J. — Generic drug maker Sandoz has launched a generic version of a drug used to treat high blood pressure and angina.

The company, a subsidiary of Swiss drug maker Novartis, announced the launch of diltiazem hydrochloride extended-release capsules, a generic version of Forest Labs' Tiazac. Sandoz is launching the drug in the 120-mg, 180-mg, 240-mg, 300-mg, 360-mg and 420-mg strengths.

Various versions of the drug had sales of about $174 million in 2012, according to IMS Health.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

Topicort topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

According to Taro, the corticosteroid spray market is approximately $100 million in annual sales in the United States.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.