Generics

PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

Mylan announced the approval of latanoprost ophthalmic solution in the 0.005% strength. The drug is a generic version of Xalatan, made by Pharmacia and Upjohn, now part of Pfizer.

Various versions of the drug had sales of around $711 million in 2010, according to IMS Health.

TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

HAYWARD, Calif. — An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it would present data from a phase-3 trial of extended-release IPX066 (carbidopa-levodopa) at the American Academy of Neurology Conference’s annual meeting in Hawaii, which takes place from April 9 through April 16.

The company also said there were no unexpected serious side effects observed in patients.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

WASHINGTON — The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

As total spending on 20 medicines with generic equivalents totaled approximately $1.5 billion, AEI concluded Medicaid overspent by 22% ($1.5 billion versus $1.17 billion) on these pharmaceuticals.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.