Content about Pharmaceutics

It’s hard to disagree that generic drug companies have had a good run for the last several years. Branded drug companies developed a large number of drugs that proved highly effective at treating widespread medical conditions and became blockbusters, garnering billions of dollars in sales in the United States alone. As patents on these blockbuster drugs have expired, they’ve provided generic manufacturers with enormous revenues, helping some to join the ranks of the world’s biggest drug companies.


SOUTH SAN FRANCISCO, Calif. — Genentech has applied for Food and Drug Administration approval of a drug for treating skin cancer, the drug maker said Monday.

Genentech, the U.S. division of Swiss drug maker Roche, submitted a new drug application to the FDA for vismodegib for the treatment of basal cell carcinoma. BCC generally is curable through surgery, but if it advances, can cause disfigurement and debilitating effects and, in the long term, can be life-threatening.

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


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

Mylan announced Friday the approval of promethazine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths.

Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.

NEW YORK — Bristol-Myers Squibb has completed its previously announced acquisition of another drug maker.

Bristol said it has completed the acquisition of small-molecule pharmaceutical company Amira Pharmaceuticals, based in San Diego, for $325 million. Amira's portfolio focuses on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases.

The transaction was originally announced on July 21.

DARMSTADT, Germany — Merck KGaA announced that Robert Yates was named president of Merck Millipore, the drug maker's life science division.

Yates will report to Bernd Reckmann, who leads the company's chemicals business sector, which includes the Merck Millipore and performance materials division. Millipore was acquired by Merck in July 2010.

Prior to his new role, Yates worked at Roche for 22 years, most recently in Roche's diagnostics division, where he led the life sciences business in Penzberg, Germany.

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."

HYDERABAD, India — Dr. Reddy’s Labs on Tuesday announced that it has launched its over-the-counter fexofenadine and pseudoephedrine extended-release tablets.

Dr. Reddy’s will market the product, the equivalent to Allegra-D 24 Hour, under store-brand labels in the U.S. market, the company stated.

Quarterly sales of Allegra-D totaled $13.5 million for the 12 weeks ended Aug. 7, according to SymphonyIRI Group tabulating sales across food, drug and mass (minus Walmart) outlets.

NEW YORK — Mylan will be banned temporarily from launching a generic drug for acne pending a federal court's decision whether or not to bar it, according to published reports.

NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. will acquire Anchen Pharmaceuticals for $410 million, Par said Wednesday.

Based in Irvine, Calif., Anchen is a privately owned generic drug maker that expects to launch eight to 10 new generic drugs over the next two years. Par plans to finance the acquisition with a $350 million term loan and cash it already has.

CINCINNATI — Prasco will market an authorized generic drug for urinary tract infections under an agreement with Shionogi, the company said Monday.

Prasco announced that it signed a supply agreement with Shinogi to market and distribute nitrofurantoin oral suspension, an authorized generic version of Furadantin. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company, such as Prasco.