Generics

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

PARSIPPANY, N.J. — Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

Actavis announced the launch of generic lidocaine topical patches in the 5% strength under a settlement agreement with Endo Pharmaceuticals and Teikoku Seiyaku Co. The drug is a generic version of Lidoderm, and Actavis said it was likely the first company to win approval for the generic from the Food and Drug Administration, thus entitling it to 180 days in which to compete exclusively against the branded version.

PARSIPPANY, N.J. — Actavis has launched a generic version of an extended-release opioid painkiller, the company said.

The drug maker announced the launch of oxymorphone extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg and 40-mg strengths. Actavis received approval for the drug in July.

The drug is a generic version of Endo's Opana ER. Endo is currently suing Actavis, alleging that Actavis' generic infringes some of its patents. The drug is used for around-the-clock pain relief.

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.