Saptalis Announces FDA Approval of Metronidazole Vaginal Gel, 0.75%

• By Saptalis
• December 31, 2024

Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Metronidazole Vaginal Gel, 0.75% (”Product”). Saptalis’s Product is therapeutically equivalent to the Reference Listed Drug (RLD), Metrogel - Vaginal®, 0.75%, Bausch Health.

Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis.

Saptalis’ Product is available in 70 gm tubes packaged with 5 vaginal applicators. The current annual U.S. market for Metronidazole Vaginal Gel, 0.75% is approximately $34 million, according to the latest estimates from IQVIA/IMS Health, with 1.7 million units sold annually.

Saptalis’s Metronidazole vaginal gel product is manufactured at its facility in Hauppauge, NY and will be launched in the next few weeks.

Saptalis Announces FDA Approval of Glycopyrrolate Oral Solution.

• By Saptalis
• October 07, 2024

Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Glycopyrrolate Oral Solution 1mg/5mL (”Product”). Saptalis’s Product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Cuvposa®, Glycopyrrolate Oral Solution, 1mg/5 mL, Merz Pharmaceuticals, LLC.

Glycopyrrolate is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Saptalis’ Product is available in 473mL Bottles.  The current annual U.S. market for Glycopyrrolate Solution is approximately $12 million, according to the latest estimates from IQVIA/IMS Health.

Saptalis plans to launch the Product in the next few weeks.

Saptalis Announces FDA Approval of Cyclosporine Ophthalmic Emulsion, 0.05%

• By Saptalis
• July 05, 2024

Saptalis Pharmaceuticals, LLC, announced today that it has received the U.S. FDA approval of its Abbreviated New Drug Application for Cyclosporine Ophthalmic Emulsion, 0.05%. Saptalis’ product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Restasis®, Abbvie, Inc. The Saptalis product is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial. Five (5) vials are packaged in an aluminum pouch; 6 or 12 such pouches are placed in a carton. The product can be dispensed as 30 vials and 60 vials.

Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular infection associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking anti-inflammatory drugs or using punctal plugs.

According to the latest estimates from IQVIA/IMS Health, the current annual U.S. market for Cyclosporine Ophthalmic Emulsion 0.05% in single dose vials is >$ 2 billion. The product is widely used, with over 250 million single dose vials dispensed annually in the US.

“Saptalis is very pleased with the FDA approval of the complex sterile ophthalmic product. The success is the result of several years of collaboration between Saptalis and our development and manufacturing partner, Taejoon Pharmaceutical Co., Ltd.“, said Dr. Polireddy Dondeti, President & CEO of Saptalis.

Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of innovative and generic products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that is US FDA – GMP approved. Saptalis manufactures and supplies to the US market a wide range of FDA approved prescription products.

Taejoon Pharmaceutical Co., Ltd. (“Taejoon”) is a leading specialty pharmaceutical company in Korea. The company specializes in ophthalmology, image contrast agents (MRI and CT), and gastrointestinal products. Taejoon is an FDA and EU-GMP approved manufacturer exporting ophthalmic products to U.S., EU and Asia.

Saptalis expects to launch Cyclosporine Ophthalmic Emulsion under Saptalis label in the next several weeks.

Saptalis Announces FDA Approval and Commercial Launch of Lithium Oral Solution.

• By Saptalis
• March 20, 2024

Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Lithium Oral Solution USP, 8 mEq/5 mL. Saptalis product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lithium Oral Solution, 8 mEq/5 mL, of Hikma Pharmaceuticals USA Inc. (Hikma). The product was discontinued by Hikma several years ago and was on the FDA Drug Shortage list until recently.

Saptalis' Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar disorder. It is approved for the treatment of acute manic and mixed episodes in patients 7 years and older, as well as maintenance treatment in patients 7 years and older.

"An estimated 2.8% of U.S. adults had bipolar disorder last year", said Dr. Polireddy Dondeti, President & CEO of Saptalis. "An estimated 4.4% of U.S. adults experience bipolar disorder at some time in their lives. Saptalis is very pleased to reintroduce to the U.S. market this highly needed liquid form of Lithium medication".

Saptalis' Lithium Oral Solution is available in two sizes: Bottles (473mL) and Unit Dose cups (5 mL). The product has currently only one generic competitor (for 473mL only) and Saptalis expects the annual market for the product to be about $6 million USD.

The product will be marketed and distributed under the Saptalis label by the Saptalis marketing team.