Generics

PARSIPPANY, N.J. — Watson Pharmaceuticals subsidiary Watson Labs has received regulatory approval for a generic oral contraceptive.

Watson Labs said its abbreviated new drug application for Vestura (3-mg drospirenone and 0.02-mg ethinyl estradiol) was approved by the Food and Drug Administration.

Watson currently is involved in patent litigation with Bayer concerning the product, which is a generic version of Bayer's Yaz oral contraceptive product.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries announced that one of its board members has resigned.

The generic drug maker confirmed the resignation of Ilan Leviteh, effective Nov. 14. Leviteh stepped down as a director due to demands on his time relating to obligations to other companies, along with concern over fulfilling the increased time commitments required of the board in light of the recent offer from Sun Pharmaceutical Industries to purchase all of Taro’s issued and outstanding shares not currently held by Sun Pharma.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

The generic drug maker announced approval of Myzilra tablets (levonorgestrel and ethinyl estradiol tablets, USP) in the 0.05-mg/0.03-mg, 0.075-mg/0.04-mg and 0.125-mg/0.03-mg (28-day triphasic regimen) strengths.

U.S. sales for Myzilra tablets totaled approximately $34.4 million for the 12 months ended Sept. 30, according to IMS Health.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

Mylan announced Monday the approval of dexrazoxane for injection, a generic version of Pharmacia & Upjohn's Zinecard. The drug is a chemoprotective agent, used to protect healthy tissue from cancer drugs.

Various versions of the drug had sales of $3.4 million during the 12-month period ended in September, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.

The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug's patent expires at the end of the month, opening the drug to generic competition.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has promoted Thomas Haughey to president and Paul Campanelli to COO, the company said. The promotions take effect immediately.

"With the acquisition of Anchen and the pending acquisition of Edict, Par is becoming a larger and more complex organization with three diverse locations and more than 300 additional employees," Par chairman and CEO Patrick LePore said. "These new challenges and opportunities require a president and COO to effectively manage the company and its subsidiaries."

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.