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November 7, 2018
ORTHO DERMATOLOGICS ANNOUNCES U.S. LAUNCH OF BRYHALI™ (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS IN ADULTS

Launch Expected to Occur Later this Month Following Final FDA Approval

RALEIGH, N.C., Nov. 7, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of BRYHALI™ (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the U.S. Food and Drug Administration (FDA) for BRYHALI Lotion on Nov. 6, 2018. BRYHALI Lotion, which is indicated for the topical treatment of plaque psoriasis in adult patients, is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks.1

1. BRYHALI™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

November 7, 2018
ORTHO DERMATOLOGICS ANNOUNCES U.S. LAUNCH OF BRYHALI™ (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS IN ADULTS

Launch Expected to Occur Later this Month Following Final FDA Approval

RALEIGH, N.C., Nov. 7, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of BRYHALI™ (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the U.S. Food and Drug Administration (FDA) for BRYHALI Lotion on Nov. 6, 2018. BRYHALI Lotion, which is indicated for the topical treatment of plaque psoriasis in adult patients, is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks.1

1. BRYHALI™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

October 30, 2018
ORTHO DERMATOLOGICS LAUNCHES ALTRENO™ (TRETINOIN) LOTION, 0.05% IN THE UNITED STATES

RALEIGH, N.C., Oct. 30, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. launch of ALTRENO™ (tretinoin) Lotion, 0.05% for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO Lotion is the first and only tretinoin available in a lotion for acne. ALTRENO Lotion has been shown to be effective and generally well-tolerated, and is provided in a formulation with known moisturizers hyaluronic acid, glycerin and collagen.1

1. ALTRENO™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

October 29, 2018
ORTHO DERMATOLOGICS LAUNCHES ALTRENO™ (TRETINOIN) LOTION, 0.05% IN THE UNITED STATES

RALEIGH, N.C., Oct. 30, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. launch of ALTRENO™ (tretinoin) Lotion, 0.05% for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO Lotion is the first and only tretinoin available in a lotion for acne. ALTRENO Lotion has been shown to be effective and generally well-tolerated, and is provided in a formulation with known moisturizers hyaluronic acid, glycerin and collagen.1

1. ALTRENO™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

October 15, 2018
ORTHO DERMATOLOGICS TO PRESENT NEW SCIENTIFIC DATA DURING THE FALL CLINICAL DERMATOLOGY CONFERENCE

16 Poster Presentations Include New Evaluations of Investigational and Existing Products

RALEIGH, N.C., Oct. 15, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21. The presentations will feature new analyses of the investigational drug DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) Lotion—including long-term evaluations of safety and maintenance of treatment success—as well as new data on SILIQ™ (brodalumab) injection, ALTRENO™ (tretinoin) Lotion, 0.05%, and BRYHALI™ (halobetasol propionate) Lotion, 0.01%, which received tentative approval from the U.S. Food and Drug Administration (FDA) on Oct. 8, 2018. Please see below for SILIQ boxed warning about suicidal ideation and behavior.

1 – Provisional Name

October 13, 2018
ORTHO DERMATOLOGICS TO PRESENT NEW SCIENTIFIC DATA DURING THE FALL CLINICAL DERMATOLOGY CONFERENCE

16 Poster Presentations Include New Evaluations of Investigational and Existing Products

RALEIGH, N.C., Oct. 15, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21. The presentations will feature new analyses of the investigational drug DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) Lotion—including long-term evaluations of safety and maintenance of treatment success—as well as new data on SILIQ™ (brodalumab) injection, ALTRENO™ (tretinoin) Lotion, 0.05%, and BRYHALI™ (halobetasol propionate) Lotion, 0.01%, which received tentative approval from the U.S. Food and Drug Administration (FDA) on Oct. 8, 2018. Please see below for SILIQ boxed warning about suicidal ideation and behavior.

1 – Provisional Name

October 11, 2018
ORTHO DERMATOLOGICS ANNOUNCES PUBLICATION OF PIVOTAL PHASE 3 EFFICACY AND SAFETY DATA ON ALTRENOTM (TRETINOIN) LOTION, 0.05% IN THE JOURNAL OF DRUGS IN DERMATOLOGY

ALTRENO Lotion Provides Statistically Significant Greater Efficacy Over Vehicle with a Favorable Safety and Tolerability Profile in Two Pivotal Clinical Trials1

RALEIGH, N.C., Oct. 11, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology has published results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of ALTRENOTM (tretinoin) Lotion, 0.05%, the first formulation of tretinoin, a retinoid, in a lotion indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.1 The U.S. Food and Drug Administration approved the New Drug Application for ALTRENO Lotion on Aug. 24, 2018.

October 11, 2018
ORTHO DERMATOLOGICS ANNOUNCES PUBLICATION OF PIVOTAL PHASE 3 EFFICACY AND SAFETY DATA ON ALTRENOTM (TRETINOIN) LOTION, 0.05% IN THE JOURNAL OF DRUGS IN DERMATOLOGY

ALTRENO Lotion Provides Statistically Significant Greater Efficacy Over Vehicle with a Favorable Safety and Tolerability Profile in Two Pivotal Clinical Trials1

RALEIGH, N.C., Oct. 11, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology has published results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of ALTRENOTM (tretinoin) Lotion, 0.05%, the first formulation of tretinoin, a retinoid, in a lotion indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.1 The U.S. Food and Drug Administration approved the New Drug Application for ALTRENO Lotion on Aug. 24, 2018.

October 8, 2018
ORTHO DERMATOLOGICS RECEIVES TENTATIVE FDA APPROVAL FOR BRYHALITM (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS
IN ADULTS

In Clinical Trials, BRYHALI Lotion Demonstrated Significant Treatment Success Over Vehicle as Early as Week Two, Which Continued Through Week 12 (Four Weeks Post Treatment)1
New Corticosteroid Lotion Formulation with Safety Proven for Up to Eight Weeks Duration of Use1
Company Plans to Launch BRYHALI Lotion in November 2018 Upon Final FDA approval

RALEIGH, N.C., Oct. 8, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALITM (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy.1 The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI shortly thereafter, as scheduled, in November 2018.

October 8, 2018
ORTHO DERMATOLOGICS RECEIVES TENTATIVE FDA APPROVAL FOR BRYHALITM (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS
IN ADULTS

In Clinical Trials, BRYHALI Lotion Demonstrated Significant Treatment Success Over Vehicle as Early as Week Two, Which Continued Through Week 12 (Four Weeks Post Treatment)1
New Corticosteroid Lotion Formulation with Safety Proven for Up to Eight Weeks Duration of Use1
Company Plans to Launch BRYHALI Lotion in November 2018 Upon Final FDA approval

RALEIGH, N.C., Oct. 8, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALITM (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy.1 The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI shortly thereafter, as scheduled, in November 2018.

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