Content about Pharmaceutical industry

PEAPACK, N.J. — Greenstone has launched an authorized generic painkiller, the company said.

Greenstone, the generics arm of Pfizer, announced the introduction of authorized generic oxaprozin caplets in the 600 mg strength. The drug is a version of Pfizer's Daypro, a non-steroidal anti-inflammatory drug, or NSAID.

Authorized generics are branded drugs sold under their generic names at a reduced price.

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

President Barack Obama sent his $3.8 trillion budget proposal to Congress on April 10, and the plan includes a number of provisions designed to cut spending on health care and promote health and wellness.

Overall, the budget is something of a mixed bag for the healthcare industry. While it would provide incentives for expanding the use of generic drugs, for example, it would also cut spending on Medicaid that have drawn opposition from pharmacy retailers, and even generic drug makers disagree with some of its provisions for that industry.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

WASHINGTON — Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

SAN DIEGO — Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

The Pharmaceutical Research and Manufacturers of America announced the election of Hugin, as well as Pfizer president and CEO Ian Read as chairman-elect of the PhRMA board of directors and Merck chairman, president and CEO as board treasurer.

Hugin succeeds Eli Lilly president, chairman and CEO John Lechleiter as chairman, PhRMA said.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.