New Drugs & OTCs

06/13/2011 - 10:48am

Merck, Hanwha to develop Enbrel biosimilar

Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

06/10/2011 - 11:41am

Forest announces availability of Daliresp

A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

06/08/2011 - 11:34am

Sandoz launches Syeda

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

06/08/2011 - 11:03am

Edison's EPI-743 granted orphan drug designation

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

06/07/2011 - 3:48pm

Mylan subsidiary gets OK for generic Aricept

Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

06/07/2011 - 2:03pm

Lannett gets PDUFA date for morphine sulfate oral solution

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

06/07/2011 - 1:56pm

Dr. Reddy's gets OK for three drugs

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

06/07/2011 - 11:42am

Topaz seeks FDA approval for head lice treatment

The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.

06/07/2011 - 10:13am

Actavis granted final approval for generic Ambien CR

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

06/07/2011 - 10:10am

Watson gets FDA nod for generic Lybrel

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.