Content about Watson Labs

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

PARSIPPANY, N.J. — Watson Pharmaceuticals subsidiary Watson Labs has received regulatory approval for a generic oral contraceptive.

Watson Labs said its abbreviated new drug application for Vestura (3-mg drospirenone and 0.02-mg ethinyl estradiol) was approved by the Food and Drug Administration.

Watson currently is involved in patent litigation with Bayer concerning the product, which is a generic version of Bayer's Yaz oral contraceptive product.

MORRISTOWN, N.J. — Watson Labs has begun shipping a drug designed to treat partial onset seizures in patients with epilepsy.

The drug maker said it launched levetiracetam extended-release tablets in the 500-mg and 750-mg strengths. The drug is a generic version of UCB's Keppra XR. The drug is indicated to treat patients ages 16 years and older.

Watson said it began shipping the drug on Tuesday following approval of its abbreviated new drug application from the Food and Drug Administration.

PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.

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.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has entered a licensing agreement with a subsidiary of Hungarian drug maker Richter to develop and market a drug for uterine fibroids, the two companies said Thursday.

Watson Labs and PregLem said European studies had shown Esmya (ulipristal acetate) to be a safe and effective treatment for the disease, a benign tumor condition that affects between one-fifth and one-fourth of women of reproductive age worldwide. Watson expected to start phase-3 studies of the drug in the United States in 2011.

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease, prompting a lawsuit from the drug’s manufacturer.

Watson said Tuesday that Watson Labs, a subsidiary of the company, had filed for approval for rasagiline mesylate tablets, a treatment for Parkinson’s used either alone or with the drug levodopa. The drug is a generic version of Teva Neuroscience’s Azilect.