On October 18, 2019, Foamix Pharmaceuticals Ltd. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has approved the Company’s novel AMZEEQ™ (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. AMZEEQ (formerly known as FMX101) is the first topical minocycline to be approved by the FDA for any condition. A copy of the press release is attached as Exhibit 99.1 to this report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Foamix Pharmaceuticals Ltd. Exhibit
EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 Exhibit 99.1 Foamix Receives FDA Approval of AMZEEQTM Topical Minocycline Treatment for Millions of Moderate to Severe Acne Sufferers AMZEEQ is the First-ever FDA Approved Topical Form of Minocycline AMZEEQ Offers Efficacy with Low Systemic Absorption REHOVOT,…
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About FOAMIX PHARMACEUTICALS LTD. (NASDAQ:FOMX)

Foamix Pharmaceuticals Ltd. is a clinical-stage specialty pharmaceutical company. The Company is focused on developing and commercializing its minocycline foam for the treatment of acne, rosacea, impetigo and other skin conditions. The Company operates in the segment of development and commercialization of foam-based formulations. The Company develops FMX101, FMX102, FMX103 and FDX104 using its technology, which includes foam-based platforms. The Company’s lead product candidate FMX101, is a novel topical foam formulation of the antibiotic minocycline. The Company develops FMX102, a minocycline foam product candidate for the treatment of impetigo, including cases of impetigo caused by methicillin-resistant staphylococcus aureus (MRSA). It is also developing FMX103, minocycline foam for rosacea. FDX104 is a topical foam formulation of the antibiotic doxycycline for the treatment of severe acne-like rashes induced by chemotherapy. It completed a Phase II clinical trial for FMX102.