Category: Products

Cosette Pharmaceuticals Announces FDA Approval of EVOXAC® (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval

Cosette Pharmaceuticals, Inc. (“Cosette”), a U.S.-based specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved EVOXAC® (cevimeline HCl) oral solution for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.

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Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), with 180 days Competitive Generic Therapy (CGT) exclusivity

Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Cosette's Abbreviated New Drug Application (ANDA) for the first generic version of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), with 180 days of Competitive Generic Therapy (CGT) exclusivity. Cosette has commenced commercial shipments, triggering the 180 days of market exclusivity.

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Ciprofloxacin Suspension 10mL Bottle and Carton

Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity

Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity. Cosette will imminently commence commercial shipments, triggering the 180 days exclusivity.

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Cosette Pharmaceuticals Partners With Mark Cuban Cost Plus Drug Company to Make CLOMID® More Affordable

Cosette Pharma announced today that it has entered into an agreement with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to offer CLOMID® (clomiPHENE citrate) 50mg tablets at a low cash price via the Cost Plus Drugs online pharmacy.

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Mark Cuban Cost Plus Drug Company + Cosette Pharmaceuticals The First Fertility Drug to Be Offered by Mark Cuban Cost Plus Drug Company

Cosette Pharmaceuticals Launches Metronidazole Vaginal Gel 0.75%, AB-rated to MetroGel-Vaginal® 0.75%

Cosette Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of MetroGel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health US, LLC.

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Metronidazole Vaginal Gel

Cosette Pharmaceuticals Launches Betaine Anhydrous Powder, AB-rated to Cystadane® (betaine anhydrous for oral solution)

Apurva Saraf, President and CEO of Cosette, stated "This launch is further evidence of Cosette's ability to partner globally and bring important drugs to the market, and furthers our transformation into a specialty pharmaceutical company.  We stay true to our firm belief of Innovating Every Day, to be a trusted partner of choice, and to continue the important work of serving U.S. patients and prescribers.”

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Cosette Pharmaceuticals Launches Betaine Anhydrous Powder, AB-rated to Cystadane®

Cosette Pharmaceuticals Announces the Approval and Launch of Metronidazole Gel USP, 1%.

Cosette Pharmaceuticals, Inc ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for Metronidazole Gel USP, 1%.

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Cosette Pharmaceuticals Announces the Approval and Launch of Metronidazole Gel USP, 1%.

Cosette Pharmaceuticals Announces the launch of Griseofulvin Oral Suspension, 125 mg/5 mL.

Cosette Pharmaceuticals, Inc began shipping Griseofulvin Oral Suspension, 125 mg/5 mL (0713-0850-04) into all channels in the United States.

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Cosette Pharmaceuticals Announces the launch of Griseofulvin Oral Suspension, 125 mg/5 mL