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Hikma/Vectura’s generic Advair delayed in the US pharmatimes
March 13, 2018
US regulators have upheld a prior decision rejecting Hikma and Vectura’s generic formulation of GlaxoSmithKline's asthma and chronic obstructive pulmonary syndrome therapy Advair Diskus.
Hikma's Advair Generic Gets Further Delayed biospace
March 13, 2018
FDA issued Hikma Pharmaceuticals a Complete Response Letter (CRL) in May 2017 for its abbreviated New Drug Application (ANDA) for its generic version, VR315, of GlaxoSmithKline’s Advair Diskus
Hikma Announces Expanded Licensing Agreement with Takeda pharmaceutical-technology
August 21, 2017
Hikma Pharmaceuticals has reached an agreement with Takeda Pharmaceutical to expand its licensing and distribution agreement adding new products to its portfolio in the Middle East and North Africa (MENA).
Hikma and Takeda sign new licensing agreement to expand product portfolio in MENA pharmaceutical-technology
August 21, 2017
Hikma Pharmaceuticals has reached an agreement with Takeda Pharmaceutical Company to expand their licensing and distribution agreement to add new products to its existing portfolio in the Middle East and North Africa (MENA).
US FDA issues CRL to Hikma’s generic version of GSK’s Advair Diskus pharmaceutical-technology
May 16, 2017
Drug Administration (FDA) for the abbreviated new drug application (ANDA) of its generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
Hikma says "low likelihood" of US approval this year for Advair generic firstwordpharma
May 12, 2017
Hikma Pharmaceuticals announced Thursday that the FDA issued a complete response letter regarding the company's filing seeking approval of a generic version of GlaxoSmithKline's asthma and chronic obstructive pulmonary disease therapy Advair Diskus (fluti
Hikma launches desvenlafaxine succinate extended-release tablets in the US market cphi-online
March 14, 2017
The tablets are indicated for the treatment of major depressive disorder.
Hikma Announces Exclusive Licensing Agreement With Orion For Its New Easyhaler Product In MENA firstwordpharma
February 21, 2017
Hikma Pharmaceuticals PLC (Hikma) announces that it has signed an exclusive licensing and distribution agreement with Orion Corporation of Finland (Orion), for its new Easyhaler® combination product.
Hikma's exclusive licensing agreement with Orion for its new Easyhaler product in MENA cphi-online
February 15, 2017
Easyhaler is a dry powder inhaler for the treatment of asthma and COPD.
Hikma Receives Approval For Sodium Oxybate Oral Solution firstwordpharma
January 19, 2017
Hikma Pharmaceuticals PLC (Hikma) announces that its wholly owned US subsidiary, Roxane Laboratories, Inc. (Roxane), has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution.

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