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Actavis receives generic opioid approval and plans name change

US generics maker Actavis announced on 20 February 2015 that it had received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Reckitt Benckiser’s Subutex (buprenorphine) sublingual tablets in dosages of 2 and 8 mg.

Mylan being sued over sorafenib generic

US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).

Dr Reddy’s could move manufacturing site with view to FDA approval

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.

Akorn submits ANDA for difluprednate ophthalmic emulsion

US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.

FDA approves first generic esomeprazole

Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.

Prasco to market authorized colchicine generic in the US

US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute an authorized generic version of Colcrys (colchicine) in the US.

US judge invalidates 4 of 5 patents on Cubicin

A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.

First celecoxib generics hit US market

On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.

FDA withdraws automatic substitution of two methylphenidate generics

The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate). The agency took the action due to concerns that the drugs may not be therapeutically equivalent to the brand-name drug.

Cipla petitions Indian Government to revoke Onbrez patents

India-based generics maker Cipla has asked the Indian Government to revoke five patents held by Swiss firm Novartis for its respiratory drug Onbrez (indacaterol), after launching its own generic version of the drug.

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