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New indication for old generic combination drug

US biopharmaceutical company Avanir Pharmaceuticals has announced positive results from a phase II clinical trial of a generic combination drug for the treatment of agitation in patients with Alzheimer’s disease. The same combination is already approved for a different neurological disorder, and other indications are being investigated.

Phase III trials for generic asthma inhaler and insulin glargine

Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.

FDA approvals for generic AIDs and testosterone drugs

The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.

Teva wins another Symbicort patent challenge

Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.

Generics companies sue Reckitt Benckisser over generics supplies

Three generics companies are suing Reckitt Benckisser (Reckitt) for failing to provide generics supplies of its cold and flu medicine Mucinex (guaifenesin) in line with an agreement struck in 2007.

US court puts generic Gralise on hold

US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment for neuropathic pain, Gralise (gabapentin).

Generics manufacturers focus on MS drug Ampyra

Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.

Blood pressure generics to be included in FDA’s testing plans

The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.

Actavis submits generic dalfampridine ANDA

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Generic valsartan approved in US

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

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