Generics

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

Watson is seeking approval for olopatadine hydrochloride ophthalmic solution in the 0.2% strength. The drug, used to treat itching in the eye resulting from allergic conjunctivitis, is a generic version of Alcon’s Pataday.

ALLEGAN, Mich. — Teva Pharmaceutical Industries has begun shipping a generic drug for allergies, partnering company Perrigo said Wednesday.

Triamcinolone acetonide nasal spray is a generic version of Sanofi’s Nasacort AQ and is used to treat nasal symptoms of seasonal and year-round allergies in patients ages 6 years and older. The Food and Drug Administration approved the generic version of the drug in 2009. The generic was made by Barr Labs, which Teva acquired a few years ago.

INDIANAPOLIS — A new oral medication for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim has become available in pharmacies, the companies said Wednesday.

Lilly and BI announced the availability of Tradjenta (linagliptin) in chain and independent pharmacies around the country.

HYDERABAD, India — The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

The drug maker said Dr. Reddy’s subsidiary Industrias Quimicas Falcon de Mexico, in Cuernavaca, received an FDA warning letter based on a November 2010 inspection where the regulatory agency found a number of manufacturing problems.

Dr. Reddy’s said it takes the warnings seriously and will respond to the FDA and work with the agency to resolve the problems.

JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

WHITEHOUSE STATION, N.J. — Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

Merck, which operates outside the United States and Canada as MSD to avoid confusion with Germany-based Merck KGaA, announced Monday a collaboration with Seoul, South Korea-based Hanwha Chemical to develop and commercialize HD203, a biosimilar version of Enbrel (etanercept), made by Amgen and Pfizer. The drug is used to treat such disorders as rheumatoid arthritis and psoriasis.

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.