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Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies

On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to. 

Mylan/Aspen launch generic busulfan injection

US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).

Drugmakers waking up to potential value of branded generics

Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a branded generic.

FDA tentatively approves pemetrexed generic

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).

EMA approval for tacrolimus generic

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.

Lupin launches generic pain-relief med in US

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.

FDA approves lidocaine ointment generic from Vitruvias Therapeutics

US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.

Indivior to appeal US ruling on opioid addiction patent

UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.

Mylan launches three HIV generics in Canada

US generics giant Mylan Pharmaceuticals (Mylan) announced on 10 August 2017 that it had launched three generic HIV drugs in Canada, after having received final approval for the products from Health Canada.

Teva launches generic testosterone

Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.