Content about Pharmaceutical industry

PHILADELPHIA — The Food and Drug Administration has granted regulatory approval for a generic drug to treat tension headaches.

Lannett announced the approval of butalbital, acetaminophen and caffeine tablets in the 50-mg/325-mg/40-mg strength. the drug is a generic version of Watson Pharmaceuticals' Fioricet.

Branded and generic versions of the drug had sales of $30 million during the 12-month period ended in July, including $15 million for branded Fioricet. Lannett plans to start shipping its version next month, the company said.

HANGZHOU, China — Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said.

NEW BRUNSWICK, N.J. — Drug maker Johnson & Johnson said Wednesday that patients applying for its HIV drug assistance program would have a more streamlined application process.

CAMBRIDGE, Mass. — A drug maker and medical research institute will work together to identify new treatments for bacterial and viral infections.

AstraZeneca and the Broad Institute, owned jointly by Harvard University and MIT, announced Monday that they would collaborate for two years to develop medicines to treat severe infections, saying the identification of high-quality chemicals for the development of new drugs was a significant challenge. The two will use the Broad Institute's collection of 100,000 chemicals known as diversity-oriented synthesis, or DOS compounds.

PITTSBURGH — Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

The Pittsburgh-based company said it settled with Pfizer over its generic version of Detrol LA (tolterodine tartrate) extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat urge urinary incontinence, urgency and frequency.

EAST HANOVER, N.J. — A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

DENVER — While the growth in healthcare costs remains a threat in the United States, the growth in drug expenditures is moderating, but numerous opportunities exist for retail, according to a speech delivered Tuesday morning at the National Association of Chain Drug Stores' 2012 Pharmacy and Technology Conference in Denver by Doug Long, VP industry relations of healthcare industry research firm IMS Health.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

Wockhardt announced the approval of felodipine extended-release tablets in the 2.5 mg, 5 mg and 10 mg strengths. The drug is a generic version of AstraZeneca's Plendil, and Wockhardt said it would launch the drug immediately.

Various versions of the drug have a market presence of more than $66 million, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA's website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

NEW YORK — The Food and Drug Administration has postponed its decision whether or not to approve an experimental arthritis drug made by Pfizer, the drug maker said.

Pfizer said the FDA had extended its action date for the drug tofacitinib by three months, to Nov. 21, because additional analyses of data that the company submitted constituted a "major amendment" to Pfizer's regulatory application and will require additional time to review.

PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic version of a diabetes drug made by Takeda Pharmaceutical, Ranbaxy said Friday.

Ranbaxy announced the launch, through subsidiary Ranbaxy Pharmaceuticals and under an agreement with Takeda, of pioglitazone hydrochloride tablets, an authorized generic version of Takeda's Actos. An authorized generic is a branded drug marketed at a reduced price under its generic name, typically by a third-party company operating under contract with the original branded drug's manufacturer.