Generics

WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs' Trandate, is used to treat hypertension.

Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.

News broke last month that officials in the South American nation of Uruguay were planning to possibly legalize marijuana. Meanwhile, activists in Colorado have sought to legalize the drug in that state, while Chicago’s city council decriminalized possession of small amounts of marijuana and reduced the penalty to a ticket.


WOODCLIFF LAKE, N.J. — An affiliate of private investment firm TPG will acquire Par Pharmaceutical Cos., the drug maker said Monday.

Par said it had entered into an agreement to be acquired for $1.9 billion. Par shareholders will receive $50 per share, representing a 37% premium over the company's Friday closing price.

Another prescription drug-related crime is drug counterfeiting, which got significant attention in March 2011 when CBS News’ “60 Minutes” reported on the problem, including a tour of a drug counterfeiting operation.


In March, the Senate passed S. 1886, the Counterfeit Drug Penalty Enhancement Act, which toughens punishments for criminals who produce and traffic counterfeit medications, drawing praise from the National Association of Chain Drug Stores.


NEW YORK — Vitamin D deficiency is associated with poor lung function in asthmatic children treated with inhaled corticosteroids, according to a new study from researchers in Boston released Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure.

The drug is a generic version of Teva Women's Health's Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.

SILVER SPRING, Md. — The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

The FDA announced the appointment of Gregory Geba as director of the Office of Generic Drugs, replacing acting director Keith Webber, effective Sunday.

Geba has served in various senior-level clinical and managerial positions in the drug industry for the past 15 years, most recently as deputy chief medical officer for Sanofi US, a subsidiary of French drug maker Sanofi.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

Watson announced that the FDA approved a subsidiary's application for diclofenac sodium and misoprostol delayed-release tablets. The drug is a generic version of G.D. Searle's Arthrotec, used to treat osteoarthritis and rheumatoid arthritis in patients who have high risk of developing ulcers related to the use of non-steroidal anti-inflammatory drugs, or NSAIDs, a class that includes the painkiller ibuprofen.