Branded

WAYNE, N.J. — The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

Safyral is a combination of Yasmin, also developed by Bayer, with 451 mcg levomefolate calcium, which is a B vitamin known as a folate. It is the second oral contraceptive from Bayer that features folate.

MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has entered a licensing agreement with a subsidiary of Hungarian drug maker Richter to develop and market a drug for uterine fibroids, the two companies said Thursday.

Watson Labs and PregLem said European studies had shown Esmya (ulipristal acetate) to be a safe and effective treatment for the disease, a benign tumor condition that affects between one-fifth and one-fourth of women of reproductive age worldwide. Watson expected to start phase-3 studies of the drug in the United States in 2011.

NEW YORK — A subsidiary of Pfizer has extended the expiration date of its tender offer to acquire all outstanding shares of common stock of King Pharmaceuticals.

Parker Tennessee's tender offer now is scheduled to expire Jan. 21, as certain conditions to the tender offer wouldn't have been satisfied by the previously scheduled expiration date — which was Dec. 17 — including the expiration or earlier termination of any waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

LONDON and HAYWARD, Calif. — GlaxoSmithKline will pay Impax Pharmaceuticals $11.5 million upfront to exclusively sell Impax's investigational Parkinson’s disease treatment.

In addition to the $11.5 million upfront payment, Impax Pharmaceuticals, the branded drug division of Impax Labs, is eligible to receive potential payments of up to $175 million upon the successful achievement of development and commercialization milestones.

DANBURY, Conn. — A drug maker specializing in the treatment of diabetes announced the retirement of its chief scientific officer.

Biodel this week said Solomon Steiner, who is a company co-founder, will remain on the company's board of directors. Prior to holding his chief scientific officer position, Steiner was chairman, president and CEO of Biodel from its inception in late 2003 through March of this year, at which point Errol De Souza was appointed to be the company's president and chief executive, and Charles Sanders was named board chairman.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

SILVER SPRING, Md. — A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

Tessalon (benzonatate) is made by Forest Labs and comes in the form of a round, liquid-filled gelatin capsule. The drug is used to relieve cough in patients older than 10 years of age.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.