Generics

PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.

HAYWARD, Calif., and HIGH POINT, N.C. — Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

Impax said it has entered a deal with Banner Pharmacaps in respect to the supply and commercialization of two softgel capsule products.

The products and terms of the agreement were not disclosed.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

NORTHVALE, N.J. — Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

The drug maker announced the initial shipment of phentermine hydrochloride tablets in the 37.5-mg strength. The drug is a generic version of Teva’s Adipex-P.

Adipex-P and generic versions had sales of about $40 million in 2010, according to IMS Health.

The shipment was made under a collaborative agreement with precision dose and its subsidiary, TAGI Pharma.

RALEIGH, N.C. — Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

Under the deal, Salix will receive exclusive worldwide rights for Xifaxan (rifaximin) drug technology developed by Lupin and jointly by both companies in all countries except India.

Salix is required to pay Lupin $10 million upfront, as well as potential payments related to regulatory milestones.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

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.