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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.

Adamis gains FDA approval for its EpiPen rival

Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.

Endo removes Opana ER opioid from the market

The US Food and Drug Administration (FDA) requested that Endo International plc (Endo) remove its opioid medication Opana ER from the market, due to concerns over the ‘public health consequences of abuse’.

Impax launches new high-strength ADHD generics

Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).

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