News

Received FDA approval for its ANDA for Levocarnitine Oral Solution

• By Saptalis
• November 10, 2021

Saptalis Pharmaceuticals, LLC announced today that it has received FDA approval for its ANDA for Levocarnitine Oral Solution 1gm/10mL.

Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. The product is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. Levocarnitine Oral Solution is a generic equivalent of Carnitor ® Oral Solution, Leadiant Biosciences, Inc. The product has annual sales of $12M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.

Received FDA approval for its sANDA for Triamcinolone Acetonide Topical Cream

• By Saptalis
• November 02, 2021

Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Cream 0.1%. Triamcinolone Acetonide Cream is a topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The product has annual sales of $57M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.

Received FDA approval for its ANDA for Potassium Chloride Oral Solution

• By Saptalis
• May 21, 2021

Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its ANDA for Potassium Chloride Oral Solution, 20 MEQ/15mL and 40 MED/15mL.

The product is indicated for the treatment of patients with hypokalemia and for the prevention of hypokalemia in patients who would be at particular risk if hyperkalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias. Potassium Chloride Oral Solution has annual sales of $60M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.

Received FDA approval for its sANDA for Triamcinolone Acetonide Topical Lotion

• By Saptalis
• March 23, 2021

Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Lotion 0.1%.

The product is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Triamcinolone Acetonide Topical Lotion 0.1% has annual sales of $6M (IQVIA) and has limited generic competition. The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.

Received FDA approval for its sANDA for Erythromycin Topical Solution

• By Saptalis
• March 18, 2021

Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Erythromycin Topical Solution 2%.

Erythromycin Topical Solution 2% is indicated for the topical treatment of acne vulgaris. The product has annual sales of $3M (IQVIA) and has limited generic competition. The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.

Received approval from the FDA for its sANDA for Acetic Acid Otic Solution USP

• By Saptalis
• July 10, 2020

Saptalis Pharmaceuticals, LLC today announced that it has received approval from the FDA for its sANDA for Acetic Acid Otic Solution USP, 2%. Acetic Acid Otic Solution USP, 2% is indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. The product has limited generic competition and has annual sales of $3M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.

Received final approval from the FDA for its ANDA for Metformin HCl Oral Solution

• By Saptalis
• March 3, 2020

Saptalis Pharmaceuticals, LLC today announced that it has received final approval from the FDA for its ANDA for Metformin HCl Oral Solution 500 mg/5mL.

Metformin HCl oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

The product is the only generic version of Riomet®, Sun Pharmaceutical Industries, Inc. which in 2019, had annual sales of $15M (IQVIA). Saptalis was first generic company to file the ANDA containing a paragraph IV certification and successfully challenged the patent for Riomet®. The FDA granted the Company a 180-day period of marketing exclusivity.

The Company will commercialize Metformin HCl Oral Solution in collaboration with its marketing & distribution partner Micro Labs, USA, Inc. and intends to ship the product before the end of March, 2020.

Entered into an exclusive licensing agreement with Appili Therapeutics Inc.

• By Saptalis
• December 3, 2019

Saptalis Pharmaceuticals, LLC today announced that it has entered into an exclusive licensing agreement with Appili Therapeutics Inc. (TSXV: APLI) for manufacturing and commercialization of ATI-1501.

ATI-501 is a proprietary, novel, taste-masked oral liquid formulation of metronidazole – a broad-spectrum and widely prescribed antibiotic used to treat parasitic and anaerobic bacterial infections which is being developed via the 505 (b) (2) pathway. Currently, oral metronidazole is only available as a solid tablet or capsule in the U.S. and Canada; no liquid oral dose forms are approved. An increasing number of patients with dysphagia (difficulty swallowing) are unable to take the tablet and require it to be crushed into food. This process amplifies the pronounced bitter taste, which can negatively impact patients’ adherence to their prescription.

Appili Therapeutics Inc, is a Halifax, Canada based biopharmaceutical company focused on anti-infective drug development. Appili will receive milestone and royalty payments on the sale of ATI-1501 in the U.S. Specific financial terms are not being disclosed.

Saptalis intends to initiate technology transfer to its manufacturing facility in Hauppauge and undertake all the necessary steps required for filing the NDA with the FDA.

Received approval for the ANDA for Clobetasol Propionate Topical Solution

• By Saptalis
• October 2, 2019

Saptalis Pharmaceuticals, LLC today announced that it has received approval for the ANDA for Clobetasol Propionate Topical Solution, USP 0.05% (25mL and 50mL).

The product is a generic version of Embeline®, Hi-Tech Pharmacal. The Company will commercialize Clobetasol Topical Solution in collaboration with its marketing & distribution partner Micro Labs, USA, Inc. and intends to ship the product before the end of 2019.