News

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.

LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a historic agreement with Apotex Inc, Canada’s largest producer of generic drugs.

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension and leukaemia and multiple myeloma generics.

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic drug. This has led to US Food and Drug Administration (FDA) approval of the drug on the agency’s abbreviated new drug application (ANDA) pathway.

On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL.

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first generic naloxone hydrochloride nasal spray, manufactured by Teva Pharmaceuticals (Teva).

In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the US.