AQUESTIVE THERAPEUTICS: Granted Temporary Restraining Order (TRO) Against Alvogen

Aquestive Therapeutics, Inc. (Nasdaq: AQST), a specialty pharmaceutical company, focused on developing and commercializing differentiated products to solve therapeutic problems, announced that the U.S. District Court for the District of New Jersey has granted a temporary restraining order (TRO) that enjoins Alvogen from initiating any launch activities related to its generic buprenorphine/naloxone sublingual film. Read More »

SUNOVION PHARMACEUTICALS INC: Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease (PD). Read More »

MYLAN INC: Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)

Wixela™ Inhub™ is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD) Read More »